List of largest pharmaceutical settlements
Table:
Year	Company	Settlement	Violation ( s )	Product ( s )	Laws allegedly violated ( if applicable )

2012	GlaxoSmithKline	$ 3 billion ( $ 1B criminal , $ 2B civil )	Criminal : Off-label promotion , failure to disclose safety data . Civil : paying kickbacks to physicians , making false and misleading statements concerning the safety of Avandia , reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program	Avandia ( not providing safety data ) , Wellbutrin , Paxil ( promotion of paediatric use ) , Advair , Lamictal , Zofran , Imitrex , Lotronex , Flovent , Valtrex ;	False Claims Act / FDCA

2009	Pfizer	$ 2.3 billion	Off-label promotion/ kickbacks	Bextra / Geodon / Zyvox / Lyrica	False Claims Act/FDCA

2013	Johnson & Johnson	$ 2.2 billion	Off-label promotion/ kickbacks	Risperdal / Invega / Nesiritide	False Claims Act/FDCA

2012	Abbott Laboratories	$ 1.5 billion	Off-label promotion	Depakote	False Claims Act/FDCA

2009	Eli Lilly	$ 1.4 billion	Off-label promotion	Zyprexa	False Claims Act/FDCA

2001	TAP Pharmaceutical Products	$ 875 million	Medicare fraud /kickbacks	Lupron	False Claims Act/ Prescription Drug Marketing Act

2012	Amgen	$ 762 million	Off-label promotion/kickbacks	Aranesp	False Claims Act/FDCA

2010	GlaxoSmithKline	$ 750 million	Poor manufacturing practices	Kytril / Bactroban / Paxil CR / Avandamet	False Claims Act/FDCA

2005	Serono	$ 704 million	Off-label promotion/ kickbacks/ monopoly practices	Serostim	False Claims Act

2008	Merck	$ 650 million	Medicare fraud/kickbacks	Zocor / Vioxx / Pepsid	False Claims Act/ Medicaid Rebate Statute

2007	Purdue Pharma	$ 601 million	Off-label promotion	Oxycontin	False Claims Act

2010	Allergan	$ 600 million	Off-label promotion	Botox	False Claims Act/FDCA

2010	AstraZeneca	$ 520 million	Off-label promotion/kickbacks	Seroquel	False Claims Act

2007	Bristol-Myers Squibb	$ 515 million	Off-label promotion/ kickbacks/Medicare fraud	Abilify / Serzone	False Claims Act/FDCA

2002	Schering-Plough	$ 500 million	Poor manufacturing practices	Claritin	FDA Current Good Manufacturing Practices

2006	Mylan	$ 465 million	Misclassification under the Medicaid Drug Rebate Program	EpiPen ( epinephrine )	False Claims Act

2006	Schering-Plough	$ 435 million	Off-label promotion/ kickbacks/Medicare fraud	Temodar / Intron A / K-Dur / Claritin RediTabs	False Claims Act/FDCA

2004	Pfizer	$ 430 million	Off-label promotion	Neurontin	False Claims Act/FDCA

2008	Cephalon	$ 425 million	Off-label promotion	Actiq / Gabitril / Provigil	False Claims Act/FDCA

2010	Novartis	$ 423 million	Off-label promotion/kickbacks	Trileptal	False Claims Act/FDCA

Taking into account the accompanying table as well as the article excerpts provided at the end.

Give the answer to the question: What was the settlement amount of the company that is headquartered in Indianapolis , Indiana , with offices in 18 countries ? Output only the correct answer as {"answer": "YOUR ANSWER"}. Do not introduce information beyond the provided sources.

GlaxoSmithKline plc ( GSK ) is a British multinational pharmaceutical company headquartered in Brentford , London . Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham , GSK was the world 's seventh largest pharmaceutical company as of 2015 , after Johnson & Johnson , Pfizer , Novartis , Merck , Hoffmann-La Roche and Sanofi . [ n 1 ] Emma Walmsley became CEO on 31 March 2017 and is the first female CEO of the company . The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index . As of August 2016 it had a market capitalisation of £81 billion ( around $ 107 billion ) , the fourth largest on the London Stock Exchange . It has a secondary listing on the New York Stock Exchange . GSK 's drugs and vaccines earned revenue of £21.3 billion in 2013 . Its top-selling products that year were Advair , Avodart , Flovent , Augmentin , Lovaza and Lamictal . GSK 's consumer products , which earned revenue of £5.2 billion in 2013 , include Sensodyne and Aquafresh toothpaste , the malted-milk drink Horlicks , Abreva for cold sores , Breathe Right nasal strips , Nicoderm and Nicorette nicotine replacements , and Night Nurse , a cold remedy . The company developed the first malaria vaccine , RTS , S , which it said in 2014 it would make available for five percent above cost . Legacy products developed at GSK include several listed in the World Health Organization Model List of Essential Medicines , such as amoxicillin , mercaptopurine , pyrimethamine and zidovudine . In 2012 , GSK pleaded guilty to promotion of drugs for unapproved uses , failure to report safety data , and kickbacks to physicians in the United States and agreed to pay a $ 3 billion ( £1.9bn ) settlement .
The Medicaid Drug Rebate Program is a program in the United States that was created by the Omnibus Budget Reconciliation Act of 1990 ( OBRA'90 ) . It requires that drug manufacturers have a national rebate agreement with the Secretary of the Department of Health and Human Services ( HHS ) in order for states to receive Federal Medicaid coverage of their products . In 2007 , 550 pharmaceutics companies participated in the Medicaid Drug Rebate Program and 49 states in addition to the District of Columbia supply drugs under the Medicaid Drug Rebate Program . In order for manufacturers to be eligible for Medicaid coverage a rebate agreement must be signed with Centers for Medicare and Medicaid Services ( CMS ) . Section 606 of the Medicare , Medicaid , and SCHIP Balanced Budget Refinement Act of 1999 ( BBRA ) amended Section 1927 ( a ) ( 1 ) allowing states to have the option of different rebate effective dates . This section states that agreements to the rebate program that have been entered on or after November 29 , 1999 may go into effect that day , and states option , any date after up to the first day of the quarter . At the time the law was enacted , managed care organizations were excluded from access to the drug rebate program . In 1990 , only 2.8 million people were enrolled in Medicaid managed care and so the savings lost by the exemption were relatively small . Today , 21 million people are enrolled in capitated managed care plans . The Drug Rebate Equalization Act of 2009 ( DRE ) , introduced in the 111th United States Congress by Representative Bart Stupak as H.R . 904 , and in the Senate by Senator Jeff Bingaman as S. 547 , would equalize the treatment of prescription drug discounts between Medicaid managed care and Medicaid fee-for-service . In offering Medicaid managed care plans access to the Medicaid drug rebate , this policy is seen as a way to provide relief for federal and state budgets , thereby mitigating the need for added cuts to Medicaid benefits or populations , and for drug carve outs , which negatively impact clinical care for Medicaid enrollees .
Rosiglitazone ( trade name Avandia ) is an antidiabetic drug in the thiazolidinedione class . It works as an insulin sensitizer , by binding to the PPAR in fat cells and making the cells more responsive to insulin . It is marketed by the pharmaceutical company GlaxoSmithKline ( GSK ) as a stand-alone drug or for use in combination with metformin or with glimepiride . First released in 1999 , annual sales peaked at approximately $ 2.5-billion in 2006 ; however , following a meta-analysis in 2007 that linked the drug 's use to an increased risk of heart attack , sales plummeted to just $ 9.5-million in 2012 . The drug 's patent expired in 2012 . It was patented in 1987 and approved for medical use in 1999 . Despite rosiglitazone 's effectiveness at decreasing blood sugar in type 2 diabetes mellitus , its use decreased dramatically as studies showed apparent associations with increased risks of heart attacks and death . Adverse effects alleged to be caused by rosiglitazone were the subject of over 13,000 lawsuits against GSK ; as of July 2010 , GSK had agreed to settlements on more than 11,500 of these suits . Some reviewers recommended rosiglitazone be taken off the market , but an FDA panel disagreed , and it remains available in the U.S. From November 2011 until November 2013 , the federal government did not allow Avandia to be sold without a prescription from a certified doctor ; moreover , patients were required to be informed of the risks associated with its use , and the drug had to be purchased by mail order through specified pharmacies . In 2013 , the FDA lifted its earlier restrictions on rosiglitazone after reviewing the results of a 2009 trial which failed to show increased heart attack risk . In Europe , the European Medicines Agency ( EMA ) recommended in September 2010 that the drug be suspended because the benefits no longer outweighed the risks . It was withdrawn from the market in the UK , Spain and India in 2010 , and in New Zealand and South Africa in 2011 .
Bupropion , sold under the brand names Wellbutrin and Zyban among others , is a medication primarily used to treat major depressive disorder and to support stopping smoking . It is an effective antidepressant on its own , but is also used as an add-on medication in cases of incomplete response to first-line SSRI antidepressants . Bupropion is taken in tablet form and is available only by prescription in most countries . Common side effects include dry mouth , trouble sleeping , agitation , and headaches . Serious side effects include an increased risk for epileptic seizures and suicide . The risk of seizures caused the drug to be withdrawn from the market for some time and then the recommended dose to be reduced . In comparison to some other antidepressants , it does not cause as much sexual dysfunction or sleepiness , and may result in weight loss . It is unclear if use during pregnancy or breastfeeding is safe . Bupropion is an atypical antidepressant . It acts as a norepinephrine-dopamine reuptake inhibitor ( NDRI ) and a nicotinic receptor antagonist . Chemically , bupropion is an aminoketone that belongs to the class of substituted cathinones and is similar to phenethylamines . Bupropion was first made by Nariman Mehta in 1969 and patented by Burroughs Wellcome in 1974 .
Paroxetine , sold under the brand names Paxil and Seroxat among others , is an antidepressant of the selective serotonin reuptake inhibitor ( SSRI ) class . It is used to treat major depressive disorder , obsessive-compulsive disorder , panic disorder , social anxiety disorder , posttraumatic stress disorder , generalized anxiety disorder and premenstrual dysphoric disorder . It has also been used in the treatment of premature ejaculation and hot flashes due to menopause . It is taken by mouth . Common side effects include drowsiness , dry mouth , loss of appetite , sweating , trouble sleeping , and sexual dysfunction . Serious side effects may include suicide in those under the age of 25 , serotonin syndrome , and mania . While the rate of side effects appear similar compared to other SSRIs and SNRIs , antidepressant discontinuation syndromes may occur more often . Use in pregnancy is not recommended while use during breastfeeding is relatively safe . It is believed to work by blocking the re-uptake of the chemical serotonin by neurons in the brain . Paroxetine was approved for medical use in the United States in 1992 and initially sold by GlaxoSmithKline . It is currently available as a generic medication . A month supply in the United Kingdom costs the NHS about £1.10 per month as of 2019 .
Fluticasone/salmeterol , sold under the brand name Advair among others , is a combination medication containing fluticasone propionate and salmeterol . It is used in the management of asthma and chronic obstructive pulmonary disease ( COPD ) . It is used by inhaling the medication into the lungs . Common side effects include thrush , headache , and cough . Serious side effects may include worsening asthma , anaphylaxis , seizures , and heart problems . Safety in pregnancy and breastfeeding is unclear . Fluticasone , a corticosteroid , works by decreasing inflammation while salmeterol , a long-acting beta-adrenoceptor agonist ( LABA ) , works by activating beta-2 adrenergic receptors . The combination was approved for medical use in the United States in 2000 . A generic version was approved in the United States in 2019 . A two month supply in the United Kingdom costs the National Health Service about £35 per month as of 2019 . In the United States the wholesale cost of this amount is about 89 USD . In 2016 , it was the 62nd most prescribed medication in the United States , with more than 12 million prescriptions .
Lamotrigine , sold as the brand name Lamictal among others , is an anticonvulsant medication used to treat epilepsy and bipolar disorder . For epilepsy , this includes focal seizures , tonic-clonic seizures , and seizures in Lennox-Gastaut syndrome . In bipolar disorder , it is used to treat acute episodes of depression and rapid cycling in bipolar type II and to prevent recurrence in bipolar type I . Common side effects include sleepiness , headache , vomiting , trouble with coordination , and rash . Serious side effects include lack of red blood cells , increased risk of suicide , Stevens-Johnson syndrome , and allergic reactions . Concerns exist that use during pregnancy or breastfeeding may result in harm . Lamotrigine is a phenyltriazine , making it chemically different from other anticonvulsants . How it works is not exactly clear . It appears to increase the action of gamma-aminobutyric acid ( GABA ) , the main inhibitory neurotransmitter in the central nervous system and decrease voltage-sensitive sodium channels . Lamotrigine was first marketed in the United Kingdom in 1991 and approved for use in the United States in 1994 . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . The wholesale cost in the developing world is about US $ 3.50 to US $ 23 per month as of 2015 .
Ondansetron , marketed under the brand name Zofran , is a medication used to prevent nausea and vomiting caused by cancer chemotherapy , radiation therapy , or surgery . It is also effective for treating gastroenteritis . It has no effect on vomiting caused by motion sickness . It can be given by mouth or by injection into a muscle or into a vein . Common side effects include diarrhea , constipation , headache , sleepiness , and itchiness . Serious side effects include QT prolongation and severe allergic reaction . It appears to be safe during pregnancy but has not been well studied in this group . It is a serotonin 5-HT3 receptor antagonist . It does not have any effect on dopamine receptors or muscarinic receptors . Ondansetron was patented in 1984 and approved for medical use in 1990 . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . It is available as a generic medication .
Sumatriptan , sold under the brand name Imitrex among others , is a medication used to treat migraine headaches and cluster headaches . It is taken by mouth , in the nose , or by injection under the skin . Effects generally occur within three hours . Common side effects include chest pressure , feeling tired , feeling of the world spinning , vomiting , tingling . Serious side effects may include serotonin syndrome , heart attacks , strokes , and seizures . With excessive use medication overuse headaches may occur . It is unclear if use in pregnancy or breastfeeding is safe . How it works is not entirely clear . It is in the triptan class of medications . Sumatriptan was patented in 1982 and approved for medical use in 1991 . It is available as a generic medication . In the United Kingdom it costs the NHS about £1 per dose as of 2019 .
Alosetron , sold under the brand name Lotronex among others , is a 5-HT3 antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome ( IBS ) in women only . It was patented in 1987 and approved for medical use in 2002 . It is currently marketed by Prometheus Laboratories Inc. ( San Diego ) . Alosetron was withdrawn from the market in 2000 owing to the occurrence of serious life-threatening gastrointestinal adverse effects , but was reintroduced in 2002 with availability and use restricted .
Fluticasone propionate , sold under the brand names Flovent and Flonase among others , is a steroid medication . When inhaled it is used for the long term management of asthma and COPD . In the nose it is used for hay fever and nasal polyps . It can also be used for mouth ulcers . Common side effects when inhaled include upper respiratory tract infections , sinusitis , thrush , and cough . Common side effects when used in the nose include nosebleeding and sore throat . It works by decreasing inflammation . Fluticasone propionate was patented in 1980 , and approved for medical use in 1990 . It is available as a generic medication . In the United States the wholesale cost per spray is about 0.33 USD as of 2018 . In the United Kingdom , it costs the NHS about 0.13 GBP per spray as of 2019 . In 2016 , it was the 16th most prescribed medication in the United States with more than 29 million prescriptions .
Valaciclovir , also spelled valacyclovir , is an antiviral medication used to treat outbreaks of herpes simplex or herpes zoster ( shingles ) . It is also used to prevent cytomegalovirus following a kidney transplant in high risk cases . It is taken by mouth . Common side effects include headache and vomiting . Severe side effects may include kidney problems . Use in pregnancy appears to be safe . It is a prodrug , which works after being converted to aciclovir in a person 's body . Valaciclovir was patented in 1987 and came into medical use in 1995 . It is available as a generic medication . A month supply in the United Kingdom costs the NHS about £3 as of 2019 . In the United States the wholesale cost of this amount is about US $ 2.80 . In 2016 it was the 168th most prescribed medication in the United States with more than 3 million prescriptions .
The False Claims Act ( FCA ) , also called the Lincoln Law , is an American federal law that imposes liability on persons and companies ( typically federal contractors ) who defraud governmental programs . It is the federal Government 's primary litigation tool in combating fraud against the Government . The law includes a qui tam provision that allows people who are not affiliated with the government , called relators under the law , to file actions on behalf of the government ( informally called whistleblowing especially when the relator is employed by the organization accused in the suit ) . Persons filing under the Act stand to receive a portion ( 15-30 percent , depending on certain factors ) of any recovered damages . As of 2019 , over 71 percent of all FCA actions were initiated by whistleblowers . Claims under the law have typically involved health care , military , or other government spending programs , and dominate the list of largest pharmaceutical settlements . The government has recovered more than $ 62 billion under the False Claims Act between 1987 and 2019 .
The United States Federal Food , Drug , and Cosmetic Act ( abbreviated as FFDCA , FDCA , or FD & C ) , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration ( FDA ) to oversee the safety of food , drugs , medical devices , and cosmetics . A principal author of this law was Royal S. Copeland , a three-term U.S . Senator from New York . In 1968 , the Electronic Product Radiation Control provisions were added to the FD & C . Also in that year the FDA formed the Drug Efficacy Study Implementation ( DESI ) to incorporate into FD & C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs . The act has been amended many times , most recently to add requirements about bioterrorism preparations . The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form ( see elixir sulfanilamide disaster ) . It replaced the earlier Pure Food and Drug Act of 1906 .
Pfizer Inc. ( /ˈfaɪzər/ ) is an American multinational pharmaceutical corporation headquartered in New York City . It is one of the world 's largest pharmaceutical companies . It is listed on the New York Stock Exchange , and its shares have been a component of the Dow Jones Industrial Average since 2004 . Pfizer ranked No . 57 on the 2018 Fortune 500 list of the largest United States corporations by total revenue . On December 19 , 2018 , Pfizer announced a joint merger of their consumer healthcare division with UK pharma giant GlaxoSmithKline ; the British company will maintain a controlling share ( listed at 68% ) . The company developed and produces medicines and vaccines for a wide range of medical disciplines , including immunology , oncology , cardiology , endocrinology , and neurology . Its products include the blockbuster drug Lipitor ( atorvastatin ) , used to lower LDL blood cholesterol ; Lyrica ( pregabalin ) for neuropathic pain and fibromyalgia ; Diflucan ( fluconazole ) , an oral antifungal medication ; Zithromax ( azithromycin ) , an antibiotic ; Viagra ( sildenafil ) for erectile dysfunction ; and Celebrex ( also Celebra , celecoxib ) , an anti-inflammatory drug . In 2016 , Pfizer Inc. was expected to merge with Allergan , plc to create the Ireland-based Pfizer plc in a deal that would have been worth $ 160 billion . The merger was called off in April 2016 , however , because of new rules from the United States Treasury against tax inversions , a method of avoiding taxes by merging with a foreign company . The company has made the second-largest pharmaceutical settlement with the United States Department of Justice .
A kickback is a form of negotiated bribery in which a commission is paid to the bribe-taker in exchange for services rendered . Generally speaking , the remuneration ( money , goods , or services handed over ) is negotiated ahead of time . The kickback varies from other kinds of bribes in that there is implied collusion between agents of the two parties , rather than one party extorting the bribe from the other . The purpose of the kickback is usually to encourage the other party to cooperate in the illegal scheme . The term kickback comes from colloquial English language , and describes the way a recipient of illegal gain kicks back a portion of it to another person for that person 's assistance in obtaining it .
Valdecoxib is a nonsteroidal anti-inflammatory drug ( NSAID ) used in the treatment of osteoarthritis , rheumatoid arthritis , and painful menstruation and menstrual symptoms . It is a selective cyclooxygenase-2 inhibitor . It was patented in 1995 . Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company as an anti-inflammatory arthritis drug . It was approved by the United States Food and Drug Administration on November 20 , 2001 , to treat arthritis and menstrual cramps . and was available by prescription in tablet form until 2005 when the FDA requested that Pfizer withdraw Bextra from the American market . The FDA cited potential increased risk for serious cardiovascular ( CV ) adverse events , an increased risk of serious skin reactions and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs . In 2009 Bextra was at the center of the largest health care fraud settlement and the largest criminal fine of any kind ever . Pfizer paid a $ 2.3 billion civil and criminal fine . Pharmacia and Upjohn , a Pfizer subsidiary , violated the United States Food , Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead . A water-soluble and injectable prodrug of valdecoxib , parecoxib is marketed in the European Union under the tradename Dynastat .
Ziprasidone , sold under the brand name Geodon among others , is an atypical antipsychotic used to treat schizophrenia and bipolar disorder . It may be used by mouth and by injection into a muscle ( IM ) . The IM form may be used for acute agitation in people with schizophrenia . Common side effects include dizziness , drowsiness , dry mouth , and twitches . Although it can also cause weight gain , the risk is much lower than for other antipsychotics . How it works is not entirely clear but is believed to involve effects on serotonin and dopamine in the brain . Ziprasidone was approved for medical use in the United States in 2001 . The pills are made up of the hydrochloride salt , ziprasidone hydrochloride . The intramuscular form is the mesylate , ziprasidone mesylate trihydrate , and is provided as a lyophilized powder .
Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics . Linezolid is active against most Gram-positive bacteria that cause disease , including streptococci , vancomycin-resistant enterococci ( VRE ) , and methicillin-resistant Staphylococcus aureus ( MRSA ) . The main uses are infections of the skin and pneumonia although it may be used for a variety of other infections including drug-resistant tuberculosis . It is used either by injection into a vein or by mouth . When given for short periods , linezolid is a relatively safe antibiotic . It can be used in people of all ages and in people with liver disease or poor kidney function . Common side effects with short-term use include headache , diarrhea , rash , and nausea . Serious side effects may include serotonin syndrome , bone marrow suppression , and high blood lactate levels , particularly when used for more than two weeks . If used for longer periods it may cause nerve damage , including optic nerve damage , which may be irreversible . As a protein synthesis inhibitor , linezolid works by suppressing bacterial protein production . This either stops growth or results in bacterial death . Although many antibiotics work this way , the exact mechanism of action of linezolid appears to be unique in that it blocks the initiation of protein production , rather than one of the later steps .
Pregabalin , marketed under the brand name Lyrica among others , is a medication used to treat epilepsy , neuropathic pain , fibromyalgia , restless leg syndrome , and generalized anxiety disorder . Its use in epilepsy is as an add-on therapy for partial seizures . When used before surgery , it reduces pain but results in greater sedation and visual disturbances . It is taken by mouth . Common side effects include headache , dizziness , sleepiness , confusion , trouble with memory , poor coordination , dry mouth , problem with vision , and weight gain . Serious side effects may include angioedema , drug misuse , and an increased suicide risk . When pregabalin is taken at high doses over a long period of time , addiction may occur , but if taken at usual doses the risk is low . Use during pregnancy or breastfeeding is of unclear safety . Pregabalin is a gabapentinoid and acts by inhibiting certain calcium channels . Pregabalin was approved for medical use in the United States in 2004 . It was developed as a successor to gabapentin . It is available as a generic medication in a number of countries , including the United States as of 2019 .
Johnson & Johnson is an American multinational corporation founded in 1886 that develops medical devices , pharmaceutical and consumer packaged goods . Its common stock is a component of the Dow Jones Industrial Average and the company is ranked No . 37 on the 2018 Fortune 500 list of the largest United States corporations by total revenue . J & J is one of the world 's most valuable companies . Johnson & Johnson is headquartered in New Brunswick , New Jersey , the consumer division being located in Skillman , New Jersey . The corporation includes some 250 subsidiary companies with operations in 60 countries and products sold in over 175 countries . Johnson & Johnson had worldwide sales of $ 70.1 billion during calendar year 2015 . Johnson & Johnson 's brands include numerous household names of medications and first aid supplies . Among its well-known consumer products are the Band-Aid Brand line of bandages , Tylenol medications , Johnson 's Baby products , Neutrogena skin and beauty products , Clean & Clear facial wash and Acuvue contact lenses .
Risperidone , sold under the brand name Risperdal among others , is an atypical antipsychotic . It is used to treat schizophrenia , bipolar disorder , and irritability associated with autism . It is taken either by mouth or by injection into a muscle . The injectable version is long-acting and lasts for about two weeks . Common side effects include movement problems , sleepiness , dizziness , trouble seeing , constipation , and increased weight . Serious side effects may include the potentially permanent movement disorder tardive dyskinesia , as well as neuroleptic malignant syndrome , an increased risk of suicide , and high blood sugar levels . In older people with psychosis as a result of dementia , it may increase the risk of dying . It is unknown if it is safe for use in pregnancy . Its mechanism of action is not entirely clear , but is believed to be related to its action as a dopamine antagonist and serotonin antagonist . Study of risperidone began in the late 1980s and it was approved for sale in the United States in 1993 . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . It is available as a generic medication .
Paliperidone , sold under the brand name Invega among others , is an atypical antipsychotic . It is marketed by Janssen Pharmaceutica . Invega is an extended release formulation of paliperidone that uses the OROS extended release system to allow for once-daily dosing . Paliperidone is mainly used to treat schizophrenia and schizoaffective disorder . Paliperidone palmitate is a long-acting injectable formulation of paliperidone palmitoyl ester indicated for once-every 28 days injection after an initial titration period .
Nesiritide ( Natrecor ) is the recombinant form of the 32 amino acid human B-type natriuretic peptide , which is normally produced by the ventricular myocardium . Nesiritide works to facilitate cardiovascular fluid homeostasis through counterregulation of the renin-angiotensin-aldosterone system , stimulating cyclic guanosine monophosphate , leading to smooth muscle cell relaxation . Nesiritide was believed initially to be beneficial for acute decompensated congestive heart failure . It received approval from the United States ' Food and Drug Administration for this purpose in 2001 after initial non-approval . In July 2011 the results of the largest study so far for nesiritide was published in The New England Journal of Medicine . The study failed to show a difference between nesiritide and placebo on mortality or re-hospitalizations .
Abbott Laboratories is an American medical devices and health care company with headquarters in the Abbott Park Business Center in Lake Bluff , Illinois , United States . The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs ; today , it sells medical devices , diagnostics , branded generic medicines and nutritional products . It split off the research-based pharmaceuticals into AbbVie in 2013 . Among its well-known products across the medical devices , diagnostics , and nutrition product divisions are Pedialyte , Similac , Ensure , Glucerna , ZonePerfect , FreeStyle Libre , i-STAT and MitraClip .
Valproate ( VPA ) , and its valproic acid , sodium valproate , and valproate semisodium forms , are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches . They are useful for the prevention of seizures in those with absence seizures , partial seizures , and generalized seizures . They can be given intravenously or by mouth . Long and short acting formulations of tablets exist . Common side effects include nausea , vomiting , sleepiness , and dry mouth . Serious side effects can include liver problems and regular monitoring of liver function tests is therefore recommended . Other serious risks include pancreatitis and an increased suicide risk . The drug is known to cause serious abnormalities in babies if taken during pregnancy . Because of this it is not typically recommended in women of childbearing age who have migraines . It is unclear exactly how valproate works . Proposed mechanisms include affecting GABA levels , blocking voltage-gated sodium channels , and inhibiting histone deacetylases . Valproic acid is a branched short-chain fatty acid ( SCFA ) made from valeric acid .
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis , Indiana , with offices in 18 countries . Its products are sold in approximately 125 countries . The company was founded in 1876 by , and named after , Col. Eli Lilly , a pharmaceutical chemist and veteran of the American Civil War . Lilly 's notable achievements include being the first company to mass-produce the polio vaccine developed by Jonas Salk , and insulin . It was one of the first pharmaceutical companies to produce human insulin using recombinant DNA including Humulin ( insulin medication ) , Humalog ( insulin lispro ) , and the first approved biosimilar insulin product in the US , Basaglar ( insulin glargine ) . Lilly is currently the largest manufacturer of psychiatric medications and produces Prozac ( fluoxetine ) , Dolophine ( methadone ) , Cymbalta ( duloxetine ) , and Zyprexa ( olanzapine ) . The company is ranked 123rd on the 2019 Fortune 500 . It is ranked 221st on the Forbes Global 2000 list of the largest public companies in the world and 252nd on the Forbes list of America 's Best Employers . Eli Lilly is a full member of the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations ( EFPIA ) . As of 1997 , it was the largest corporation and the largest charitable benefactor in Indiana .
Olanzapine , sold under the trade name Zyprexa among others , is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder . For schizophrenia , it can be used for both new onset disease and long term maintenance . It is taken by mouth or by injection into a muscle . Common side effects include weight gain , movement disorders , dizziness , feeling tired , constipation , and dry mouth . Other side effects include low blood pressure with standing , allergic reactions , neuroleptic malignant syndrome , high blood sugar , seizures , gynecomastia , erectile dysfunction , and tardive dyskinesia . In older people with dementia , its use increases the risk of death . Use in the later part of pregnancy may result in a movement disorder in the baby for some time after birth . Although how it works is not entirely clear , it blocks dopamine and serotonin receptors . Olanzapine was patented in 1971 and approved for medical use in the United States in 1996 . It is available as a generic medication . In the United States , the wholesale cost is less than US $ 0.25 per dose as of 2018 . In 2016 , it was prescribed more than 2 million times in the United States .
TAP Pharmaceuticals was formed in 1977 as a joint venture between the two global pharmaceutical companies , Abbott Laboratories and Takeda Pharmaceutical Co. and was dissolved in 2008 ; its two most successful products were proton-pump inhibitor lansoprazole ( Prevacid ) and the prostate cancer drug , leuprorelin ( Lupron ) . The intention of the joint venture was to get products that Takeda had discovered developed , approved , and marketed in the US and Canada . The company was established at a time when Japanese pharmaceutical companies were seeking partnerships to access the US market . These efforts were supported by the Japanese government at the time to help the national economy compete in higher technology , as countries like South Korea , Taiwan were beginning to catch up with Japan in commodity production . Japanese pharmaceutical companies were especially strong in the fields of generating analogs of known cephalosporin antibiotics , cancer drugs , and cardiovascular drugs . The first products TAP file new drug applications for , were two cephalosporins , cefmenoxime ( Cefmax ) and cefsulodin ( Cefonomil ) , estazolam for sleep disorders , and leuprorelin ; leuprorelin was the first one approved , in 1985 . In 1998 Takeda established its own US R & D and sales force , for the diabetes drug pioglitazone ( Actos ) . In 2000 , TAP 's withdrew its new drug application for apomorphine ( branded as Uprima ) as a treatment for erectile dysfunction after an FDA review panel raised questions about the drug 's safety , due to many clinical trial subjects fainting after taking the drug . In 2001 , the US Department of Justice , states attorneys general , and TAP Pharmaceutical Products settled criminal and civil charges against TAP related to federal and state medicare fraud and illegal marketing of the drug leuprorelin . TAP paid a total of $ 875 million , which was a record high at the time . The $ 875 million settlement broke down to $ 290 million for violating the Prescription Drug Marketing Act , $ 559.5 million to settle federal fraud charges for overcharging Medicare , and $ 25.5 million reimbursement to 50 states and Washington , D.C. , for filing false claims with the states ' Medicaid programs . The case arose under the False Claims Act with claims filed by Douglas Durand , a former TAP vice president of sales , and Joseph Gerstein , a doctor at Tufts University 's HMO practice .
In the United States , Medicare fraud is the claiming of Medicare health care reimbursement to which the claimant is not entitled . There are many different types of Medicare fraud , all of which have the same goal : to collect money from the Medicare program illegitimately . The total amount of Medicare fraud is difficult to track , because not all fraud is detected and not all suspicious claims turn out to be fraudulent . According to the Office of Management and Budget , Medicare improper payments were $ 47.9 billion in 2010 , but some of these payments later turned out to be valid . The Congressional Budget Office estimates that total Medicare spending was $ 528 billion in 2010 .
Leuprorelin , also known as leuprolide , is a manufactured version of a hormone used to treat prostate cancer , breast cancer , endometriosis , uterine fibroids , and early puberty . It is given by injection into a muscle or under the skin . Common side effects include hot flashes , unstable mood , trouble sleeping , headaches , and pain at the site of injection . Other side effects may include high blood sugar , allergic reactions , and problems with the pituitary gland . Use during pregnancy may harm the baby . Leuprorelin is in the gonadotropin-releasing hormone ( GnRH ) analogue family of medications . It works by decreasing gonadotropin and therefore decreasing testosterone and estradiol . Leuprorelin was patented in 1973 and approved for medical use in the United States in 1985 . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . In the United Kingdom a monthly dose costs the NHS about GB£75.24 . In the United States the equivalent dose has a wholesale cost of US $ 1,011.93 . It is sold under the brand name Lupron among others .
The Prescription Drug Marketing Act ( PDMA ) of 1987 ( P.L . 100-293 , 102 Stat . 95 ) is a law of the United States federal government . It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit , adulterated , misbranded , subpotent , and expired prescription drugs . It was passed in response to the development of a wholesale sub-market ( known as the diversion market ) for prescription drugs . The PDMA was modified by the Prescription Drug Amendments of 1992 ( P.L . 102-353 , 106 Stat . 941 ) on August 26 , 1992 . The U.S. Food and Drug Administration ( FDA ) issued regulations implementing the PDMA in 1990 ( 21 C.F.R . Part 205 ) and 1999 ( 21 C.F.R . Part 203 ) .
Amgen Inc. ( formerly Applied Molecular Genetics Inc. ) is an American multinational biopharmaceutical company headquartered in Thousand Oaks , California . One of the world 's largest independent biotechnology companies , Amgen was established in Thousand Oaks , California in 1980 . Amgen 's Thousand Oaks staff in 2017 numbered 5,125 ( 7.5% of total city employment ) and included hundreds of scientists , making Amgen the largest employer in Ventura County . Focused on molecular biology and biochemistry , its goal is to provide a healthcare business based on recombinant DNA technology . In 2018 , the company 's largest selling product lines were Neulasta , an immunostimulator used to prevent infections in patients undergoing cancer chemotherapy and Enbrel , a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and other autoimmune diseases . Other products include Epogen , Aranesp , Sensipar/Mimpara , Nplate , Vectibix , Prolia and XGEVA . Amgen sponsors the Tour of California .
Darbepoetin alfa ( INN ) /dɑːrbəˈpoʊɪtɪn/ is a re-engineered form of erythropoietin containing 5 amino acid changes ( N30 , T32 , V87 , N88 , T90 ) resulting in the creation of 2 new sites for N-linked carbohydrate addition . It has a 3-fold longer serum half-life compared to epoetin alpha and epoetin beta . It stimulates erythropoiesis ( increases red blood cell levels ) by the same mechanism as rHuEpo ( binding and activating the Epo receptor ) and is used to treat anemia , commonly associated with chronic kidney failure and cancer chemotherapy . Darbepoetin is marketed by Amgen under the trade name Aranesp . The medication was approved in September 2001 by the Food and Drug Administration for treatment of anemia in patients with chronic kidney failure by intravenous or subcutaneous injection . In June 2001 , it had been approved by the European Medicines Agency for this indication as well as the treatment of anemia in cancer patients undergoing chemotherapy . Dr. Reddy 's Laboratories launched darbepoetin alfa in India under the brand name Cresp in August 2010 . This is the worlds first follow-on biologic of darbepoetin alfa . Darbepoetin is produced by recombinant DNA technology in modified Chinese hamster ovary cells . It differs from endogenous erythropoietin ( EPO ) by containing two more N-linked oligosaccharide chains . It is an erythropoiesis-stimulating 165-amino acid protein .
Granisetron is a serotonin 5-HT3 receptor antagonist used as an antiemetic to treat nausea and vomiting following chemotherapy and radiotherapy . Its main effect is to reduce the activity of the vagus nerve , which is a nerve that activates the vomiting center in the medulla oblongata . It does not have much effect on vomiting due to motion sickness . This drug does not have any effect on dopamine receptors or muscarinic receptors . Granisetron was developed by chemists working at the British drug company Beecham around 1988 and is available as a generic . It is produced by Roche Laboratories under the trade name Kytril . The drug was approved in the United Kingdom in 1991 and in United States in 1994 by the FDA . A granisetron transdermal patch with the trade name Sancuso was approved by the US FDA on September 12 , 2008 . Sancuso is manufactured by 3M Drug Delivery Systems for Kyowa Kirin , Inc. Granisetron is metabolized slowly by the liver , giving it a longer than average half-life . One dose usually lasts 4 to 9 hours and is usually administered once or twice daily . This drug is removed from the body by the liver and kidneys . It was patented in 1985 and approved for medical use in 1991 .
Mupirocin , sold under the brand name Bactroban among others , is a topical antibiotic useful against superficial skin infections such as impetigo or folliculitis . It may also be used to get rid of methicillin-resistant S. aureus ( MRSA ) when present in the nose without symptoms . Due to concerns of developing resistance , use for greater than ten days is not recommended . It is used as a cream or ointment applied to the skin . Common side effects include itchiness and rash at the site of application , headache , and nausea . Long term use may result in increased growth of fungi . Use during pregnancy and breastfeeding appears to be safe . Mupirocin is in the carboxylic acid class of medications . It works by blocking a bacteria 's ability to make protein , which usually results in bacterial death . Mupirocin was initially isolated in 1971 from Pseudomonas fluorescens . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . The wholesale cost in the developing world is about US $ 2.10 for a 15 g tube .
Metformin , marketed under the trade name Glucophage among others , is the first-line medication for the treatment of type 2 diabetes , particularly in people who are overweight . It is also used in the treatment of polycystic ovary syndrome . It is not associated with weight gain . It is taken by mouth . Metformin is generally well tolerated . Common side effects include diarrhea , nausea , and abdominal pain . It has a low risk of causing low blood sugar . High blood lactic acid level is a concern if the medication is prescribed inappropriately or in overly large doses . It should not be used in those with significant liver disease or kidney problems . While no clear harm comes from use during pregnancy , insulin is generally preferred for gestational diabetes . Metformin is a biguanide antihyperglycemic agent . It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues .
Serono was a biotechnology company headquartered in Geneva , Switzerland . It was acquired by the German pharmaceutical company Merck in 2006 . The company was founded as the Serono Pharmacological Institute by Cesare Serono in 1906 in Italy . A key step in its development was the discovery of a method of extracting urinary gonadotropins by Dr Piero Donini . Serono was incorporated in 1987 and the holding company , Ares-Serono S.A. , changed its name to Serono S.A. in May 2000 . Serono develops and markets pharmaceuticals in the fields of reproductive health , multiple sclerosis , growth & metabolism and dermatology . The eight biotechnology products are available in four core therapeutic areas : neurology for the treatment of relapsing forms of multiple sclerosis , reproductive health for treatments of infertility , dermatology , where Serono has launched biologics in Europe for moderate-to-severe psoriasis , and growth and metabolism for treatments for HIV-associated wasting and growth deficiencies . The Company also conducts research in oncology and autoimmune diseases . Through the acquisition in 1997 of GBRI from GlaxoWelcome , becoming its Geneva based research institute named SPRI , and the Manteia Predictive Medicine spin-off , Serono also nursed the emergence of now a commercial leading massive parallel sequencing technology .
A monopoly ( from Greek μόνος , mónos , 'single , alone ' and πωλεῖν , pōleîn , 'to sell ' ) exists when a specific person or enterprise is the only supplier of a particular commodity . This contrasts with a monopsony which relates to a single entity 's control of a market to purchase a good or service , and with oligopoly which consists of a few sellers dominating a market . Monopolies are thus characterized by a lack of economic competition to produce the good or service , a lack of viable substitute goods , and the possibility of a high monopoly price well above the seller 's marginal cost that leads to a high monopoly profit . The verb monopolise or monopolize refers to the process by which a company gains the ability to raise prices or exclude competitors . In economics , a monopoly is a single seller . In law , a monopoly is a business entity that has significant market power , that is , the power to charge overly high prices . Although monopolies may be big businesses , size is not a characteristic of a monopoly . A small business may still have the power to raise prices in a small industry ( or market ) .
Serostim ( recombinant DNA somatropin ) is Serono 's brand name prescription drug form of synthetic growth hormone , marketed for HIV-associated wasting . In December 2007 , the U.S. District Court of Massachusetts - in a class-action lawsuit that involved Merck Serono and Serostim - fined Serono a total of $ 704 million in criminal and civil liabilities for enacting illegal schemes to promote , market and sell its drug .
Merck & Co. , Inc. , d.b.a . Merck Sharp & Dohme ( MSD ) outside the United States and Canada , is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world . Merck is incorporated in New Jersey . The company was established in 1891 as the United States subsidiary of the German company Merck , which was founded in 1668 by the Merck family . Merck & Co. was expropriated by the US government during World War I and subsequently established as an independent American company in 1917 . While it operates as Merck & Co. in the United States and Canada , the original Merck based in Darmstadt holds the rights to the Merck name everywhere else . Merck & Co. is the world 's seventh largest pharmaceutical company by market capitalization and revenue . Its headquarters is located in Kenilworth , New Jersey . The company ranked No . 78 in the 2018 Fortune 500 list of the largest United States corporations by total revenue . Merck & Co. publishes The Merck Manuals , a series of medical reference books for physicians , nurses , technicians , and veterinarians . These include the Merck Manual of Diagnosis and Therapy , the world 's best-selling medical reference .
Simvastatin , marketed under the trade name Zocor among others , is a lipid-lowering medication . It is used along with exercise , diet , and weight loss to decrease elevated lipid levels . It is also used to decrease the risk of heart problems in those at high risk . It is taken by mouth . Common side effects include constipation , headaches , and nausea . Serious side effects may include muscle breakdown , liver problems , and increased blood sugar levels . A lower dose may be needed in people with kidney problems . There is evidence of harm to the developing baby when taken during pregnancy and it should not be used by those who are breastfeeding . It is in the statin class of medications and works by decreasing the manufacture of cholesterol by the liver . Simvastatin was patented by Merck in 1980 , and came into medical use in 1992 . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . It is available as a generic medication .
Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug ( NSAID ) . It was marketed by Merck & Co. to treat osteoarthritis , rheumatoid arthritis , juvenile rheumatoid arthritis , acute pain conditions , migraine , and dysmenorrhea . Rofecoxib was approved in the US by the US Food and Drug Administration ( FDA ) in May 1999 , and was marketed under the brand names Vioxx , Ceoxx , and Ceeoxx . Rofecoxib was available by prescription in both tablet-form and as an oral suspension . Rofecoxib gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain . Worldwide , over 80 million people were prescribed rofecoxib at some time . In September 2004 , Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term , high-dosage use . Merck withdrew the drug after disclosures that it withheld information about rofecoxib 's risks from doctors and patients for over five years , allegedly resulting in between 88,000 and 140,000 cases of serious heart disease . Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market . In the year before withdrawal , Merck had sales revenue of US $ 2.5 billion from Vioxx . In 2005 the FDA issued a memo concluding that data from large long-term controlled clinical trials do not clearly demonstrate that COX-2 selective agents ( including rofecoxib ) have a greater risk of serious CV events than non-selective NSAIDs . The FDA reinforced this position in 2015 , stating that the available data support a dose and duration dependent class effect of an increased risk of serious adverse cardiovascular events for COX-2 selective and non-selective NSAIDs .
Famotidine , sold under the trade name Pepcid among others , is a medication that decreases stomach acid production . It is used to treat peptic ulcer disease , gastroesophageal reflux disease , and Zollinger-Ellison syndrome . It is taken by mouth or by injection into a vein . It begins working within an hour . Common side effects include headache , intestinal upset , and dizziness . Serious side effects may include pneumonia and seizures . Use in pregnancy appears safe but has not been well studied while use during breastfeeding is not recommended . It is a histamine H2 receptor antagonist . Famotidine was patented in 1979 and came into medical use in 1985 . It is available as a generic medication . A month supply in the United Kingdom costs the NHS about £30 as of 2019 . In the United States the wholesale cost of this amount is about $ 2 .
Purdue Pharma L.P. is a privately held pharmaceutical company founded by John Purdue Gray . It is owned principally by descendants of Mortimer and Raymond Sackler . In 2007 , it paid out one of the largest fines ever levied against a pharmaceutical firm for mislabeling its product OxyContin , and three executives were found guilty of criminal charges . Although the company shifted its focus to abuse-deterrent formulations , Purdue continued to market and sell opioids , and continued to be involved in lawsuits around the opioid epidemic in the United States . Purdue filed for Chapter 11 bankruptcy protection on September 15 , 2019 in New York .
Oxycodone , sold under brand name OxyContin among others , is an opioid medication used for treatment of moderate to severe pain . It is usually taken by mouth , and is available in immediate-release and controlled-release formulations . Onset of pain relief typically begins within 15 minutes and lasts for up to six hours with the immediate-release formulation . In the United Kingdom , it is available by injection . Combination products are also available with paracetamol ( acetaminophen ) or aspirin . Common side effects include constipation , nausea , sleepiness , dizziness , itching , dry mouth , and sweating . Severe side effects may include addiction , respiratory depression ( a reduction in breathing ) , and low blood pressure . Those allergic to codeine may also be allergic to oxycodone . Use of oxycodone in early pregnancy appears relatively safe . Opioid withdrawal may occur if rapidly stopped . Oxycodone acts by activating the μ-opioid receptor . When taken by mouth , it has roughly 1.5 times the effect of the equivalent amount of morphine .
Allergan plc is an Irish-domiciled pharmaceutical company that acquires , develops , and markets brand name drugs , and in 2017 generated 80% net sales from the U.S. healthcare system . Allergan plc was formed in February 2015 when Irish-registered Actavis plc acquired U.S.-registered Allergan , Inc. , and assumed the Allergan name . Actavis was a 2013 U.S. tax inversion that moved its legal domicile to Ireland to avoid U.S. taxes . Actavis used the Irish low-tax corporate system to acquire large U.S. pharmaceutical firms ( e.g . Forest Labs , Allergan Inc. ) , and redomicile them to Ireland . In 2016 , the U.S. Treasury blocked Actavis from executing what would have been the largest corporate tax inversion in history , in a $ 160 billion merger with Pfizer . In 2016 , the generics unit was sold to Teva . In June 2019 , U.S. pharmaceutical company AbbVie announced it had reached an agreement to acquire Allergan for $ 63 billion ; however the transaction would not be structured as a tax inversion , and that post the transaction , the Group would be domiciled in the U.S. for tax purposes . Allergan acquires , develops , reprices and markets branded products in six therapeutic areas : aesthetics/dermatology/plastic surgery ; neurosciences/CNS ; eye care ; womens health and urology ; GI and cystic fibrosis ; and cardiovascular disease and infectious disease .
Botulinum toxin ( Botox ) is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species . It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis . Infection with the bacterium causes the disease botulism . The toxin is also used commercially for medical and cosmetic purposes . There are seven main types of botulinum toxin , named type A-G. New types are occasionally found . Types A and B are capable of causing disease in humans , and are also used commercially and medically . Types C-G are less common ; types E and F can cause disease in humans , while the other types cause disease in other animals . Botulinum toxin types A and B are used in medicine to treat various muscle spasms . Botulinum toxin is the most acutely lethal toxin known . Intoxication can occur naturally as a result of either wound or intestinal infection or by ingesting preformed toxin in food . The estimated human median lethal dose ( LD50 ) of type A toxin is 1.3-2.1 ng/kg intravenously or intramuscularly , 10-13 ng/kg when inhaled , or 1000 ng/kg when taken by mouth . Commercial forms are marketed under the brand names Botox ( onabotulinumtoxinA ) , Dysport/Azzalure ( abobotulinumtoxinA ) , Xeomin/Bocouture ( incobotulinumtoxinA ) , and Jeuveau ( prabotulinumtoxinA ) .
AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company . In 2013 , it moved its headquarters to Cambridge , United Kingdom , and concentrated its R & D in three sites : Cambridge ; Gaithersburg , Maryland , USA ( location of MedImmune ) for work on biopharmaceuticals ; and Mölndal ( near Gothenburg ) in Sweden , for research on traditional chemical drugs . AstraZeneca has a portfolio of products for major disease areas including cancer , cardiovascular , gastrointestinal , infection , neuroscience , respiratory and inflammation . The company was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group ( itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993 ) . Since the merger it has been among the world 's largest pharmaceutical companies and has made numerous corporate acquisitions , including Cambridge Antibody Technology ( in 2006 ) , MedImmune ( in 2007 ) , Spirogen ( in 2013 ) and Definiens ( by MedImmune in 2014 ) . AstraZeneca has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index . It has secondary listings on the New York Stock Exchange and the OMX exchange .
Quetiapine , sold under the trade name Seroquel among others , is an atypical antipsychotic used for the treatment of schizophrenia , bipolar disorder , and major depressive disorder . Despite being widely used as a sleep aid due its sedating effect , the benefits of such use do not appear to generally outweigh the side effects . It is taken by mouth . Common side effects include sleepiness , constipation , weight gain , and dry mouth . Other side effects include low blood pressure with standing , seizures , a prolonged erection , high blood sugar , tardive dyskinesia , and neuroleptic malignant syndrome . In older people with dementia , its use increases the risk of death . Use in the third trimester of pregnancy may result in a movement disorder in the baby for some time after birth . Quetiapine is believed to work by blocking a number of receptors including serotonin and dopamine . Quetiapine was developed in 1985 and approved for medical use in the United States in 1997 . It is available as a generic medication . In the United States , the wholesale cost is about US $ 12 per month as of 2017 . In the United Kingdom , a month 's supply costs the NHS about £60 as of 2017 .
Bristol-Myers Squibb Company is an American pharmaceutical company , headquartered in New York City . [ citation needed ] Bristol-Myers Squibb manufactures prescription pharmaceuticals and biologics in several therapeutic areas , including cancer , HIV/AIDS , cardiovascular disease , diabetes , hepatitis , rheumatoid arthritis and psychiatric disorders . BMS ' primary R & D sites are located in Lawrence , New Jersey ( formerly Squibb , near Princeton ) , New Brunswick , New Jersey , and Redwood City , California ; with other sites in Devens and Cambridge , Massachusetts , East Syracuse , New York , Braine-l'Alleud , Belgium , Tokyo , Japan , and Bangalore , India . BMS previously had an R & D site in Wallingford , Connecticut ( formerly Bristol-Myers ) .
Aripiprazole , sold under the brand name Abilify among others , is an atypical antipsychotic . It is primarily used in the treatment of schizophrenia and bipolar disorder . Other uses include as an add-on treatment in major depressive disorder , tic disorders and irritability associated with autism . It is taken by mouth or injection into a muscle . A Cochrane review found only low quality evidence of effectiveness in treating schizophrenia . Additionally , since many people dropped out of the studies before they were completed , the strength of the conclusions was low . Common side effects include vomiting , constipation , sleepiness , dizziness , weight gain and movement disorders . Serious side effects may include neuroleptic malignant syndrome , tardive dyskinesia and anaphylaxis . It is not recommended for older people with dementia-related psychosis due to an increased risk of death . In pregnancy , there is evidence of possible harm to the baby . It is not recommended in women who are breastfeeding . It has not been very well studied in people less than 18 years old .
Nefazodone , sold formerly under the brand names Serzone , Dutonin , and Nefadar among others , is an atypical antidepressant which was first marketed by Bristol-Myers Squibb in 1994 but has since largely been discontinued . BMS withdrew it from the market by 2004 due to decreasing sales due to the rare incidence of severe liver damage and the onset of generic competition . The incidence of severe liver damage is approximately 1 in every 250,000 to 300,000 patient-years . Generic versions were introduced in 2003 . Nefazodone is a phenylpiperazine compound and is related to trazodone . It has been described as a serotonin antagonist and reuptake inhibitor ( SARI ) due to its combined actions as a potent serotonin 5-HT2A receptor and 5-HT2C receptor antagonist and weak serotonin-norepinephrine-dopamine reuptake inhibitor ( SNDRI ) .
Schering-Plough Corporation was a United States-based pharmaceutical company . It was originally the US subsidiary of the German company Schering AG , which was founded in 1851 by Ernst Christian Friedrich Schering . As a result of nationalization it became an independent company . In 1971 , the Schering Corporation merged with Plough ( founded by Memphis area entrepreneur Abe Plough in 1908 ) to form Schering-Plough . On November 4 , 2009 Merck & Co. merged with Schering-Plough with the new company taking the name of Merck & Co. Schering-Plough manufactured several pharmaceutical drugs , the most well-known of which were the allergy drugs Claritin and Clarinex , an anti-cholesterol drug Vytorin , and a brain tumor drug Temodar . These are now available from Merck & Co. Schering-Plough also owned and operated the major foot care brand name Dr. Scholl 's and the skin care line Coppertone . These also became a part of the new company . As of June 2005 [ update ] , Schering-Plough had 1.4% market share in the U.S. , placing it seventeenth in the top twenty pharmaceutical corporations by sales compiled by IMS Health . [ citation needed ] Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations ( EFPIA ) , a membership which is also maintained by the new Merck & Co .
Loratadine , sold under the brand name Claritin among others , is a medication used to treat allergies . This includes allergic rhinitis ( hay fever ) and hives . It is also available in combination with pseudoephedrine , a decongestant , known as loratadine/pseudoephedrine . It is taken by mouth . Common side effects include sleepiness , dry mouth , and headache . Serious side effects are rare and include allergic reactions , seizures , and liver problems . Use during pregnancy appears to be safe but has not been well studied . It is not recommended in children less than two years old . It is in the second-generation antihistamine family of medication . Loratadine was patented in 1980 and came to market in 1988 . It is on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system . Loratadine is available as a generic medication .
The Food and Drug Administration ( FDA or USFDA ) is a federal agency of the United States Department of Health and Human Services , one of the United States federal executive departments . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco products , dietary supplements , prescription and over-the-counter pharmaceutical drugs ( medications ) , vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices ( ERED ) , cosmetics , animal foods & feed and veterinary products . The FDA was empowered by the United States Congress to enforce the Federal Food , Drug , and Cosmetic Act , which serves as the primary focus for the Agency ; the FDA also enforces other laws , notably Section 361 of the Public Health Service Act and associated regulations , many of which are not directly related to food or drugs . These include regulating lasers , cellular phones , condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction . The FDA is led by the Commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The Commissioner reports to the Secretary of Health and Human Services . Stephen M. Hahn , MD is the acting commissioner , as of December 2019 [ update ] . The FDA has its headquarters in unincorporated White Oak , Maryland . The agency also has 223 field offices and 13 laboratories located throughout the 50 states , the United States Virgin Islands , and Puerto Rico . In 2008 , the FDA began to post employees to foreign countries , including China , India , Costa Rica , Chile , Belgium , and the United Kingdom .
Good manufacturing practices ( GMP ) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages , cosmetics , pharmaceutical products , dietary supplements , and medical devices . These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality , from batch to batch , for their intended use . The rules that govern each industry may differ significantly ; however , the main purpose of GMP is always to prevent harm from occurring to the end user . Additional tenets include ensuring the end product is free from contamination , that it is consistent in its manufacture , that its manufacture has been well documented , that personnel are well trained , and the product has been checked for quality more than just at the end phase . GMP is typically ensured through the effective use of a quality management system ( QMS ) . Good manufacturing practices , along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United Kingdom , United States , Canada , Europe , China , India and other countries .
Mylan N.V. is a global generic and specialty pharmaceuticals company domiciled in the Netherlands , with principal executive offices in Hatfield , Hertfordshire , UK and a Global Center in Canonsburg , Pennsylvania , US . In 2007 , Mylan acquired a controlling interest in India-based Matrix Laboratories Limited , a top producer of active pharmaceutical ingredients ( APIs ) for generic drugs , and the generics business of Germany-based Merck KGaA . Through these acquisitions , Mylan grew from the third-largest generic and pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world . Mylan went public on the OTC market in February 1973 . It is listed on the NASDAQ , and its shares are a component of the NASDAQ Biotechnology and the S & P 500 indices . The company develops and produces medicines for a wide range of medical disciplines , including oncology , anaphylaxis , antiretrovirals , cardiovascular , respiratory , dermatology , immunology , anesthesia and pain management , infectious disease , gastroenterology , diabetology/endocrinology , and women 's healthcare . In 2016 , Mylan 's pricing of the EpiPen , an epinephrine autoinjector , became controversial and was widely referred to as price gouging . As a result , investigations were opened into whether Mylan had misclassified the EpiPen under the Medicaid Drug Rebate Program , a common form of pharmaceutical fraud . In October 2016 , Mylan settled these investigations with the U.S. Department of Justice , agreeing to pay $ 465 million and enter into a corporate integrity agreement concerning the rebate program . In a report published on June 12 , 2017 Institutional Shareholder Services criticized Mylan for the outsized compensation of Mylan 's directors . Former CEO Robert Coury received a $ 98 million 2016 pay package in spite of shareholder losses and the perceived harm to the company inflicted by the EpiPen controversies . The report urged Mylan 's shareholders to oust all of Mylan 's existing directors .
An epinephrine autoinjector ( or adrenaline autoinjector , commonly known as an EpiPen ) is a medical device for injecting a measured dose or doses of epinephrine ( adrenaline ) by means of autoinjector technology . It is most often used for the treatment of anaphylaxis . The first epinephrine autoinjector was brought to market in the 1980s .
Adrenaline , also known as epinephrine , is a hormone and medication . Adrenaline is normally produced by both the adrenal glands and a small number of neurons in the medulla oblongata , where it acts as a neurotransmitter involved in regulating visceral functions ( e.g. , respiration ) . It plays an important role in the fight-or-flight response by increasing blood flow to muscles , output of the heart , pupil dilation response and blood sugar level . It does this by binding to alpha and beta receptors . It is found in many animals and some single-celled organisms . Polish physiologist Napoleon Cybulski first isolated epinephrine in 1895 .
Temozolomide ( TMZ ; brand names Temodar and Temodal and Temcad ) is an oral chemotherapy drug . It is an alkylating agent used as a treatment of some brain cancers ; as a second-line treatment for astrocytoma and a first-line treatment for glioblastoma multiforme .
Interferon alfa 2b is an antiviral or antineoplastic drug , that was originally discovered in the laboratory of Charles Weissmann at the University of Zurich . It was developed at Biogen , and ultimately marketed by Schering-Plough under the tradename Intron-A . It has been used for a wide range of indications , including viral infections and cancers . This drug is approved around the world for the treatment of chronic hepatitis C , chronic hepatitis B , hairy cell leukemia , Behçet 's disease , chronic myelogenous leukemia , multiple myeloma , follicular lymphoma , carcinoid tumor , mastocytosis and malignant melanoma .
Potassium chloride ( also known as KCl or potassium salt ) is a metal halide salt composed of potassium and chlorine . It is odorless and has a white or colorless vitreous crystal appearance . The solid dissolves readily in water , and its solutions have a salt-like taste . KCl is used as a fertilizer , in medicine , in scientific applications , and in food processing , where it may be known as E number additive E508 . In a few states of the United States , it is used to cause cardiac arrest , as the third drug in the three drug cocktail for executions by lethal injection . It occurs naturally as the mineral sylvite , and in combination with sodium chloride as sylvinite .
Gabapentin , sold under the brand name Neurontin among others , is an anticonvulsant medication used to treat partial seizures , neuropathic pain , hot flashes , and restless legs syndrome . It is recommended as one of a number of first-line medications for the treatment of neuropathic pain caused by diabetic neuropathy , postherpetic neuralgia , and central neuropathic pain . About 15% of those given gabapentin for diabetic neuropathy or postherpetic neuralgia have a measurable benefit . Gabapentin is taken by mouth . Common side effects include sleepiness and dizziness . Serious side effects include an increased risk of suicide , aggressive behavior , and drug reactions . It is unclear if it is safe during pregnancy or breastfeeding . Lower doses are recommended in those with kidney disease associated with a low kidney function . Gabapentin is a gabapentinoid . It has a molecular structure similar to that of the neurotransmitter γ-aminobutyric acid ( GABA ) and acts by inhibiting certain calcium channels . Gabapentin was first approved for use in 1993 . It has been available as a generic medication in the United States since 2004 .
Cephalon , Inc. was an American biopharmaceutical company co-founded in 1987 by pharmacologist Frank Baldino , Jr. , neuroscientist Michael Lewis , and organic chemist James C. Kauer - all three former scientists with the DuPont Company . [ not verified in body ] Baldino served as Cephalon 's chairman and chief executive officer , [ not verified in body ] until his death in December 2010 . The company 's name comes from the adjective cephalic meaning related to the head or brain , as it was established primarily to pursue treatments for neurodegenerative diseases . [ not verified in body ] As noted by fundinguniverse.com , in its early years ,
Fentanyl , also spelled fentanil , is an opioid used as a pain medication and together with other medications for anesthesia . Fentanyl is also used as a recreational drug , often mixed with heroin or cocaine . It has a rapid onset and its effects generally last less than two hours . Medically , fentanyl is used by injection , as a patch on the skin , as a nasal spray , or in the mouth . Common side effects include vomiting , constipation , sedation , confusion , hallucinations , and injuries related to poor coordination . Serious side effects may include decreased breathing ( respiratory depression ) , serotonin syndrome , low blood pressure , addiction , or coma . Fentanyl works primarily by activating μ-opioid receptors . It is around 100 times stronger than morphine , and some analogues such as carfentanil are around 10,000 times stronger . Fentanyl was first made by Paul Janssen in 1960 and approved for medical use in the United States in 1968 . In 2015 , 1,600 kilograms ( 3,500 lb ) were used in healthcare globally . As of 2017 [ update ] , fentanyl was the most widely used synthetic opioid in medicine . Fentanyl patches for cancer pain are on the World Health Organization 's List of Essential Medicines , the safest and most effective medicines needed in a health system .
Tiagabine ( trade name Gabitril ) is an anticonvulsant medication produced by Cephalon that is used in the treatment of epilepsy . The drug is also used off-label in the treatment of anxiety disorders and panic disorder .
Modafinil , sold under the brand name Provigil among others , is a medication to treat sleepiness due to narcolepsy , shift work sleep disorder , or obstructive sleep apnea . While it has seen off-label use as a purported cognitive enhancer , the research on its effectiveness for this use is not conclusive . It is taken by mouth . Common side effects include headache , anxiety , trouble sleeping , and nausea . Serious side effects may include allergic reactions such as anaphylaxis , Stevens-Johnson syndrome , misuse , and hallucinations . It is unclear if use during pregnancy is safe . The amount of medication used may need to be adjusted in those with kidney or liver problems . It is not recommended in those with an arrhythmia , significant hypertension , or left ventricular hypertrophy . How it works is not entirely clear . One possibility is that it may affect the areas of the brain involved with the sleep cycle . Modafinil was approved for medical use in the United States in 1998 . In the United States it is classified as a schedule IV controlled substance .
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel , Switzerland . It is one of the largest pharmaceutical companies by both market capitalization and sales . Novartis manufactures the drugs clozapine ( Clozaril ) , diclofenac ( Voltaren ) , carbamazepine ( Tegretol ) , valsartan ( Diovan ) , imatinib mesylate ( Gleevec/Glivec ) , ciclosporin ( Neoral/Sandimmun ) , letrozole ( Femara ) , methylphenidate ( Ritalin ) , terbinafine ( Lamisil ) , and others . In 1996 , Ciba-Geigy merged with Sandoz ; the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity . Ciba-Geigy and Sandoz businesses were sold , or , like Ciba Specialty Chemicals , spun off as independent companies . The Sandoz brand disappeared for three years , but was revived in 2003 when Novartis consolidated its generic drugs businesses into a single subsidiary and named it Sandoz . Novartis divested its agrochemical and genetically modified crops business in 2000 with the spinout of Syngenta in partnership with AstraZeneca , which also divested its agrochemical business . Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations ( EFPIA ) , the International Federation of Pharmaceutical Manufacturers and Associations ( IFPMA ) , and the Pharmaceutical Research and Manufacturers of America ( PhRMA ) .
Oxcarbazepine , sold under the brand name Trileptal among others , is a medication used to treat epilepsy and bipolar disorder . For epilepsy it is used for both focal seizures and generalized seizures . It has been used both alone and as add-on therapy in people with bipolar who have had no success with other treatments . It is taken by mouth . Common side effects include nausea , vomiting , dizziness , drowsiness , double vision and trouble with walking . Serious side effects may include anaphylaxis , liver problems , pancreatitis , suicide , and an abnormal heart beat . While use during pregnancy may harm the baby , use may be less risky than having a seizure . Use is not recommended during breastfeeding . In those with an allergy to carbamazepine there is a 25% risk of problems with oxcarbazepine . How it works is not entirely clear . Oxcarbazepine was patented in 1969 and came into medical use in 1990 . It is available as a generic medication .