[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applications be withdrawn.
DATES: Approval is withdrawn as of April 15, 2021.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, [email protected].
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.
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Application No. Drug Applicant
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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.
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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