Document ID: FDA-2021-N-0212-0001
Agency: fda
Document Type: Notice
Title: Bristol-Meyers Squibb Company, et al.; Withdrawal of Approval of 19 New Drug Applications
Posted Date: 2021-03-16T04:00Z

[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14447-14448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05368]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0212]

Bristol-Meyers Squibb Company, et al.; Withdrawal of Approval of 
19 New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 19 new drug applications (NDAs) from multiple 
applicants. The applicants notified the Agency in writing that the drug 
products were no longer marketed and requested that the approval of the 
applications be withdrawn.

DATES: Approval is withdrawn as of April 15, 2021.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, Kimberly.Lehrfeld@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The applicants listed in the table have 
informed FDA that these drug products are no longer marketed and have 
requested that FDA withdraw approval of the applications under 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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 009218.............  Coumadin (warfarin       Bristol-Myers Squibb
                          sodium) Tablets, 1       Co., P.O. Box 4000,
                          milligram (mg), 2 mg,    Princeton, NJ 08543.
                          2.5 mg, 3 mg, 4 mg, 5
                          mg, 6 mg, 7.5 mg, and
                          10 mg.
                         Coumadin (warfarin
                          sodium) Injection, 5
                          mg/vial, 50 mg/vial,
                          and 75 mg/vial.
NDA 011664.............  Decadron                 Merck Sharp & Dohme
                          (dexamethasone)          Corp., a subsidiary
                          Tablets, 0.25 mg, 0.5    of Merck & Co., Inc.,
                          mg, 0.75 mg, 1.5 mg, 4   1 Merck Dr.,
                          mg, and 6 mg.            Whitehouse Station,
                                                   NJ 08889.
NDA 017481.............  Vermox (mebendazole)     Janssen
                          Chewable Tablets, 100    Pharmaceuticals,
                          mg.                      Inc., 1125 Trenton-
                                                   Harbourton Rd.,
                                                   Titusville, NJ 08560.
NDA 018538.............  Lozol (indapamide)       Sanofi-aventis U.S.
                          Tablets, 1.25 mg, and    LLC, 55 Corporate
                          2.5 mg.                  Dr., Bridgewater, NJ
                                                   08807.
NDA 018986.............  Pralidoxime Chloride     Meridian Medical
                          Injection (auto-         Technologies, Inc.,
                          injector), 600 mg/2      1945 Craig Rd., St.
                          milliliters (mL) (300    Louis, MO 63146.
                          mg/mL).
NDA 019999.............  Morphine Sulfate         Do.
                          Injection (auto-
                          injector), 10 mg/0.7
                          mL.
NDA 020363.............  Famvir (famciclovir)     Novartis
                          Tablets, 125 mg, 250     Pharmaceuticals
                          mg, and 500 mg.          Corp., 1 Health
                                                   Plaza, East Hanover,
                                                   NJ 07936-1080.
NDA 020711.............  Zyban (bupropion         GlaxoSmithKline LLC, 5
                          hydrochloride (HCl))     Crescent Dr.,
                          Extended-Release         Philadelphia, PA
                          Tablets, 100 mg, and     19112.
                          150 mg.
NDA 020809.............  Diclofenac Sodium        Alcon Research, LLC,
                          Ophthalmic Solution,     6201 South Freeway,
                          0.1%.                    Fort Worth, TX 76134.
NDA 021713.............  Abilify (aripiprazole)   Otsuka Pharmaceutical
                          Oral Solution, 1 mg/mL.  Co., Ltd. c/o Otsuka
                                                   Pharmaceutical
                                                   Development &
                                                   Commercialization,
                                                   Inc., 2440 Research
                                                   Blvd., Rockville, MD
                                                   20850.
NDA 021729.............  Abilify (aripiprazole)   Do.
                          Discmelt Orally
                          Disintegrating
                          Tablets, 10 mg, 15 mg,
                          20 mg, and 30 mg.
NDA 021866.............  Abilify (aripiprazole)   Do.
                          Injection, 9.75 mg/1.3
                          mL (7.5 mg/mL).
NDA 022024.............  Actoplus Met XR          Takeda Pharmaceutical
                          (metformin HCl and       U.S.A. Inc., 95
                          pioglitazone) Extended-  Hayden Ave.,
                          Release Tablets, 1gram   Lexington, MA 02421.
                          (g)/Equivalent to (EQ)
                          15 mg base and 1 g/EQ
                          30 mg base.
NDA 050605.............  Ceftin (cefuroxime       GlaxoSmithKline
                          axetil) Tablets, EQ      Intellectual Property
                          125 mg base, EQ 250 mg   (no. 2) Ltd. England,
                          base, and EQ 500 mg      c/o GlaxoSmithKline,
                          base.                    1250 South
                                                   Collegeville Rd.,
                                                   Collegeville, PA
                                                   19426.
NDA 050672.............  Ceftin (cefuroxime       Do.
                          axetil) Oral
                          Suspension, EQ 125 mg
                          base/5 mL and EQ 250
                          mg base/5 mL.
NDA 207988.............  Zurampic (lesinurad)     Ironwood
                          Tablets, 200mg.          Pharmaceuticals,
                                                   Inc., 100 Summer St.,
                                                   Suite 2300, Boston MA
                                                   02110.
NDA 208383.............  Bevyxxa (betrixaban)     Portola
                          Capsules, 40 mg and 80   Pharmaceuticals,
                          mg.                      Inc., 270 East Grand
                                                   Ave., South San
                                                   Francisco, CA 94080.
NDA 210709.............  Tekturna (aliskiren      Nodem Pharma DAC, 4820
                          hemifumarate) Capsules   Emperor Blvd.,
                          (Pellets), EQ 37.5 mg    Durham, NC 27703.
                          base.
NDA 210874.............  Qternmet XR              AstraZeneca AB, c/o
                          (dapagliflozin,          AstraZeneca
                          metformin HCl and        Pharmaceuticals LP,
                          saxagliptin) Extended-   1800 Concord Pike,
                          Release Tablets, 2.5     Wilmington, DE 19803.
                          mg/1 g/EQ 2.5 mg base,
                          5 mg/1 g/EQ 2.5 mg
                          base, 5 mg/1 g/EQ 5 mg
                          base, and 10 mg/1 g/EQ
                          5 mg base.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of April 
15, 2021. Approval of each entire application is withdrawn, including 
any strengths and dosage forms inadvertently missing from the table. 
Introduction or delivery for introduction into interstate commerce of 
products without approved new drug applications violates section 301(a) 
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) 
and (d)). Drug products that are listed in the table

[[Page 14448]]

that are in inventory on April 15, 2021 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: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05368 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P