Document ID: FDA-2014-N-1795-0001
Agency: fda
Document Type: Notice
Title: Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications
Posted Date: 2014-12-05T05:00Z

[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72186-72188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28541]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1795]

Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug 
Applications and 68 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 23 new drug applications (NDAs) and 68 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the Agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: Effective Date: January 5, 2015.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 in this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications pursuant to the process in Sec.  314.150(c) (21 CFR 
314.150(c)). The applicants have also, by their requests, waived their 
opportunity for a hearing. Withdrawal of approval of an application or 
abbreviated application under Sec.  314.150(c) is without prejudice to 
refiling.

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 002852.............  Plexofer                 Mallinckrodt Inc., 675
                          (multivitamins) Syrup.   McDonnell Blvd.,
                                                   Hazelwood, MO 63042.
NDA 008719.............  Levo-Dromoran            Valeant
                          (levorphanol tartrate)   Pharmaceuticals North
                          Injection, 2             America LLC, 400
                          milligrams (mg)/         Somerset Corporate
                          milliliter (mL).         Blvd., Bridgewater,
                                                   NJ 08807.
NDA 008720.............  Levo-Dromoran            Do.
                          (levorphanol tartrate)
                          Tablets, 2 mg.
NDA 011777.............  Sodium Phosphate P 32    Mallinckrodt Inc.
                          Solution.
NDA 012366.............  Soma Compound with       Meda Pharmaceuticals
                          Codeine (carisoprodol,   Inc., 265 Davidson
                          aspirin, and codeine     Ave., Suite 300,
                          phosphate).              Somerset, NJ 08873-
                                                   4120.
NDA 012708.............  Diutensen-R              Do.
                          (methyclothiazide and
                          reserpine) Tablets,
                          2.5 mg/0.1 mg.
NDA 016245.............  Vercyte (pipobroman)     AbbVie, Inc., 1 North
                          Tablets.                 Waukegan Rd., Dept.
                                                   PA 77/Bldg. AP30,
                                                   North Chicago, IL
                                                   60064.
NDA 017463.............  Motrin (ibuprofen)       McNeil Consumer
                          Tablets, 300 mg, 400     Healthcare Division
                          mg, 600 mg, and 800 mg.  of McNeil-PPC, Inc.,
                                                   7050 Camp Hill Rd.,
                                                   Fort Washington, PA
                                                   19034-2299.
NDA 018310.............  Lymphazurin (isosulfan   Covidien, 60
                          blue), 1%.               Middletown Ave.,
                                                   North Haven, CT
                                                   06473.
NDA 018340.............  Aerobid (flunisolide)    Roche Palo Alto LLC, c/
                          Inhalation Aerosol \1\.  o Genentech Inc., 1
                                                   DNA Way, South San
                                                   Francisco, CA 94080-
                                                   4990.
NDA 018731.............  Buspar (buspirone        Bristol-Myers Squibb
                          hydrochloride (HCl))     Co., P.O. Box 4000,
                          Tablets, 5 mg, 10 mg,    Princeton, NJ 08543-
                          15 mg, and 30 mg.        4000.
NDA 019453.............  Drixoral                 Merck Consumer Care,
                          (dexbrompheniramine      556 Morris Ave.,
                          maleate,                 Summit, NJ 07901.
                          pseudoephedrine
                          sulfate, and
                          acetaminophen)
                          Extended-Release
                          Tablets, 3 mg, 60 mg,
                          and 500 mg.

[[Page 72187]]

 
NDA 019842.............  Motrin (ibuprofen)       McNeil Consumer
                          Suspension, 100 mg/5     Healthcare Division
                          mL.                      of McNeil-PPC, Inc.
NDA 020150.............  Nicotrol TD (nicotine    Do.
                          transdermal system), 5
                          mg/16 hour (hr), 10 mg/
                          16 hr, and 15 mg/16 hr.
NDA 020707.............  Skelid (tiludronate      Sanofi-Aventis U.S.
                          disodium) Tablets.       LLC, 55 Corporate
                                                   Dr., Mailstop 55C-
                                                   205A, Bridgewater, NJ
                                                   08807.
NDA 021043.............  RID Mousse (pyrethrins   Bayer Healthcare LLC,
                          0.33% and piperonyl      100 Bayer Blvd.,
                          butoxide 4.0%) Topical   Whippany, NJ 07981-
                          Aerosol.                 0915.
NDA 021082.............  Tavist Allergy Sinus     Novartis Consumer
                          Headache (clemastine     Health, Inc., 200
                          fumarate,                Kimball Dr.,
                          pseudoephedrine HCl,     Parsippany, NJ 07054.
                          and acetaminophen)
                          Tablets, 0.335 mg, 30
                          mg, and 500 mg.
NDA 021190.............  Buspar (buspirone HCl)   Bristol-Myers Squibb
                          Capsules, 5 mg, 7.5      Co.
                          mg, 10 mg, and 15 mg.
NDA 021335.............  Gleevac (imatinib        Novartis
                          mesylate) Capsules, 50   Pharmaceuticals
                          mg and 100 mg.           Corp., One Health
                                                   Plaza, East Hanover,
                                                   NJ 07936.
NDA 021745.............  Ryzolt (tramadol HCl)    Purdue Pharma Products
                          Extended-Release         L.P., One Stamford
                          Tablets, 100 mg, 200     Forum, Stamford, CT
                          mg, and 300 mg.          06901-3431.
NDA 022217.............  Valturna (aliskiren and  Novartis
                          valsartan) Tablets.      Pharmaceuticals Corp.
NDA 022470.............  Nexcede (ketoprofen)     Novartis Consumer
                          Oral Soluble Films,      Health, Inc.
                          12.5 mg.
ANDA 040034............  Theophylline Extended-   Inwood Laboratories,
                          Release Tablets, 450     Inc., Subsidiary of
                          mg.                      Forest Laboratories,
                                                   Inc., Harborside
                                                   Financial Center,
                                                   Plaza Five, Suite
                                                   1900, Jersey City, NJ
                                                   07311.
ANDA 040052............  Theophylline Extended-   Do.
                          Release Capsules, 100
                          mg, 125 mg, 200 mg,
                          and 300 mg.
ANDA 040365............  Dextroamphetamine        Nesher Pharmaceutical
                          Sulfate Tablets, 5 mg.   (USA) LLC, 13910
                                                   Saint Charles Rock
                                                   Rd., Bridgeton, MO
                                                   63044.
ANDA 040367............  Dextroamphetamine        Do.
                          Sulfate Tablets, 10 mg.
ANDA 060578............  Mycostatin Topical       Delcor Asset Corp., c/
                          Powder (nystatin         o Prestium Pharma
                          topical powder USP)      Inc., 411 South State
                          100,000 units/gram (g).  St., Suite E-100,
                                                   Newtown, PA 18940.
ANDA 062162............  Erythromycin Estolate    Barr Laboratories,
                          Capsules USP, 125 mg     Inc., Subsidiary of
                          and 250 mg.              Teva Pharmaceuticals
                                                   USA, 400 Chestnut
                                                   Ridge Rd., Woodcliff
                                                   Lake, NJ 07677.
ANDA 062256............  Erythromycin             Do.
                          Ethylsuccinate Tablets
                          USP, 400 mg.
ANDA 062773............  Cephalexin Capsules USP  Do.
                          250 mg.
ANDA 062850............  Cephradine Capsules USP  Do.
                          250 mg.
ANDA 062851............  Cephradine Capsules USP  Do.
                          500 mg.
ANDA 062858............  Cephradine for Oral      Do.
                          Suspension USP 125 mg/
                          5 mL.
ANDA 062859............  Cephradine for Oral      Do.
                          Suspension USP, 250 mg/
                          5 mL.
ANDA 063016............  Cefazolin for Injection  Teva Pharmaceuticals
                          USP 250 mg/vial, 500     USA, 425 Privet Rd.,
                          mg/vial, and 1 g/vial.   Horsham, PA 19044.
ANDA 063028............  Erythromycin Delayed-    Barr Laboratories,
                          Release Tablets USP,     Inc., Subsidiary of
                          333 mg.                  Teva Pharmaceuticals
                                                   USA.
ANDA 063086............  Erythromycin Delayed-    Do.
                          Release Tablets, 333
                          mg.
ANDA 063098............  Erythromycin Delayed-    Do.
                          Release Capsules USP,
                          250 mg.
ANDA 063179............  Erythromycin Stearate    ANI Pharmaceuticals,
                          Tablets USP 500 mg.      Inc., 210 Main St.
                                                   West, Baudette, MN
                                                   56623.
ANDA 064191............  Cefuroxime for           Teva Pharmaceuticals
                          Injection USP 7.5 g/     USA.
                          vial.
ANDA 064192............  Cefuroxime for           Do.
                          Injection USP 750 mg/
                          vial and 1.5 g/vial.
ANDA 065032............  Doxycycline Capsules     Sandoz Inc., 4700
                          USP 50 mg and 100 mg.    Sandoz Dr., Wilson,
                                                   NC 27893.
ANDA 065227............  Ceftriaxone for          Teva Pharmaceuticals
                          Injection USP, 250 mg/   USA.
                          vial, 500 mg/vial, 1 g/
                          vial, and 2 g/vial.
ANDA 065262............  Ceftriaxone for          Do.
                          Injection USP, 1 g/
                          vial and 2 g/vial.
ANDA 065274............  Ceftriaxone for          Do.
                          Injection USP, 10 g/
                          vial.
ANDA 070034............  Sulfamethoxazole and     Teva Pharmaceuticals
                          Trimethoprim Tablets     USA.
                          USP 400 mg/80 mg.
ANDA 070216............  Sulfamethoxazole and     Barr Laboratories
                          Trimethoprim Tablets     Inc., Subsidiary of
                          USP 800 mg/160 mg.       Teva Pharmaceuticals.
ANDA 072410............  Indomethacin Extended-   Inwood Laboratories,
                          Release Capsules, 75     Inc., Subsidiary of
                          mg.                      Forest Laboratories,
                                                   Inc.
ANDA 072499............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 60 mg.
ANDA 072500............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 80 mg.
ANDA 072501............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 120 mg.
ANDA 072502............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 160 mg.
ANDA 072619............  Albuterol Sulfate        Teva Pharmaceuticals
                          Tablets USP 2 mg.        USA.
ANDA 072620............  Albuterol Sulfate        Do.
                          Tablets USP 4 mg.
ANDA 073095............  Clemastine Fumerate      Do.
                          Syrup, 0.5 mg/5 mL.
ANDA 073531............  Potassium Chloride       Do.
                          Extended-Release
                          Capsules USP, 8
                          milliequivalents (mEq).
ANDA 073532............  Potassium Chloride       Do.
                          Extended-Release
                          Capsules USP, 10 mEq.
ANDA 073667............  Nortriptyline HCl        Do.
                          Capsules, 10 mg, 25
                          mg, 50 mg, and 75 mg.
ANDA 074043............  Piroxicam Capsules USP,  Mylan Pharmaceuticals,
                          10 mg and 20 mg.         Inc., 781 Chestnut
                                                   Ridge Rd., P.O. Box
                                                   4310, Morgantown, WV
                                                   26505.

[[Page 72188]]

 
ANDA 074126............  Atenolol Tablets USP,    Do.
                          25 mg, 50 mg, and 100
                          mg.
ANDA 074589............  Minoxidil Topical        Teva Pharmaceuticals
                          Solution, 2%.            USA.
ANDA 074828............  Acyclovir Capsules, 200  Do.
                          mg.
ANDA 074849............  Clomipramine HCl         Do.
                          Capsules, 25 mg, 50
                          mg, and 75 mg.
ANDA 074879............  Ketoprofen Extended-     Alkermes Gainesville
                          Release Capsules, 200    LLC, 1300 Gould Dr.,
                          mg.                      Gainesville, GA
                                                   30504.
ANDA 074976............  Acyclovir Tablets USP,   Mylan Pharmaceuticals,
                          400 mg and 800 mg.       Inc.
ANDA 074977............  Acyclovir Capsules USP,  Do.
                          200 mg.
ANDA 075161............  Ticlopidine HCl Tablets  Do.
                          USP, 250 mg.
ANDA 075472............  Enalapril Maleate        Do.
                          Tablets USP, 2.5 mg, 5
                          mg, 10 mg, and 20 mg.
ANDA 075934............  Nizatidine Capsules      Do.
                          USP, 150 mg and 300 mg.
ANDA 076036............  Quinapril Tablets USP,   Do.
                          5 mg, 10 mg, 20 mg,
                          and 40 mg.
ANDA 076969............  Metoprolol Succinate     Sandoz, Inc.
                          Extended-Release
                          Tablets USP, 25 mg, 50
                          mg, 100 mg, and 200 mg.
ANDA 077136............  Terbinafine HCl          Mylan Pharmaceuticals,
                          Tablets, 250 mg.         Inc.
ANDA 077163............  Sumatriptan Succinate    Do.
                          Tablets, 25 mg, 50 mg,
                          and 100 mg.
ANDA 077254............  Divalproex Sodium        Do.
                          Delayed-Release
                          Tablets USP, 125 mg,
                          250 mg, and 500 mg.
ANDA 077486............  Glimepiride Tablets      Do.
                          USP, 1 mg, 2 mg, and 4
                          mg.
ANDA 077705............  Fosinopril Sodium and    Do.
                          Hydrochlorothiazide
                          Tablets, 10 mg/12.5 mg
                          and 20 mg/12.5 mg.
ANDA 077934............  Meloxicam Tablets USP,   Do.
                          7.5 mg and 15 mg.
ANDA 077976............  Cromolyn Sodium Nasal    HH & P LLC, c/o Kuker
                          Solution USP, 5.2 mg/1   Regulatory
                          spray.                   Consulting, LLC, 18
                                                   Dunbar Way,
                                                   Mahtomedi, MN 55115.
ANDA 078638............  Alendronate Sodium       Mylan Pharmaceuticals,
                          Tablets USP, 35 mg and   Inc.
                          70 mg.
ANDA 078731............  Levetiracetam Tablets,   Do.
                          250 mg, 500 mg, 750
                          mg, and 1,000 mg.
ANDA 079184............  Ursodiol Tablets USP,    Teva Pharmaceuticals
                          250 mg and 500 mg.       USA.
ANDA 081295............  Estradiol Tablets USP,   Bristol-Myers Squibb
                          0.5 mg.                  Co.
ANDA 084499............  Estradiol Tablets USP,   Do.
                          1 mg.
ANDA 084500............  Estradiol Tablets USP,   Do.
                          2 mg.
ANDA 085794............  Acetaminophen and        Mutual Pharmaceutical
                          Codeine Phosphate        Co., Inc., 1100
                          Tablets USP, 300 mg/30   Orthodox St.,
                          mg.                      Philadelphia, PA
                                                   19124.
ANDA 085795............  Acetaminophen and        Do.
                          Codeine Phosphate
                          Tablets USP, 300 mg/15
                          mg.
ANDA 087176............  Chlorthalidone Tablets   Ivax Pharmaceuticals,
                          USP, 50 mg.              Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, 400 Chestnut
                                                   Ridge Rd., Woodcliff
                                                   Lake, NJ 07677.
ANDA 087653............  Acetaminophen and        Mutual Pharmaceutical
                          Codeine Phosphate        Co., Inc.
                          Tablets USP, 300 mg/60
                          mg.
ANDA 088833............  Triprolidine HCl,        Wockhardt Bio AG, c/o
                          pseudoephedrine HCl,     Morton Grove
                          and Codeine Phosphate    Pharmaceuticals,
                          Cough Syrup, 1.25 mg/5   Inc., 6451 Main St.,
                          mL, 30 mg/5 mL, and 10   Morton Grove, IL
                          mg/5 mL.                 60053.
ANDA 088896............  Promethazine VC with     Do.
                          Codeine (promethazine
                          HCl, phenylephrine
                          HCl, and codeine
                          phosphate) Cough
                          Syrup, 6.25 mg/5 mL, 5
                          mg/5 mL, and 10 mg/5
                          mL.
NDA 202343.............  Juvisync (sitagliptin    Merck Sharp & Dohme
                          and simvastatin)         Corp., 351 North
                          Tablets, 100 mg/10 mg,   Sumneytown Pike, P.O.
                          100 mg/20 mg, and 100    Box 1000, UG2CD-015,
                          mg/40 mg.                North Wales, PA
                                                   19454.
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\1\ This product included an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any flunisolide metered-dose
  inhalers (see 75 FR 19213, April 14, 2010).

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority 
delegated to the Director, Center for Drug Evaluation and Research, by 
the Commissioner, approval of the applications listed in table 1 in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective January 5, 2015. Introduction or delivery for 
introduction into interstate commerce of products without approved new 
drug applications violates section 301(a) and (d) of the FD&C Act (21 
U.S.C. 331(a) and (d)). Drug products that are listed in Table 1 that 
are in inventory on the date that this notice becomes effective (see 
the DATES section) may continue to be dispensed until the inventories 
have been depleted or the drug products have reached their expiration 
dates or otherwise become violative, whichever occurs first.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28541 Filed 12-4-14; 8:45 am]
BILLING CODE 4164-01-P