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AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of April 15, 2021.
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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.
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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 § 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 § 314.150(c) is without prejudice to refiling.
| Application No. | Drug | Applicant |
|---|
| NDA 009218 | Coumadin (warfarin sodium) Tablets, 1 milligram (mg), 2 mg, 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 | Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543. |
| NDA 011664 | Decadron (dexamethasone) Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg, and 6 mg | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 1 Merck Dr., Whitehouse Station, NJ 08889. |
| NDA 017481 | Vermox (mebendazole) Chewable Tablets, 100 mg | Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. |
| NDA 018538 | Lozol (indapamide) Tablets, 1.25 mg, and 2.5 mg | Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 018986 | Pralidoxime Chloride Injection (auto-injector), 600 mg/2 milliliters (mL) (300 mg/mL) | Meridian Medical Technologies, Inc., 1945 Craig Rd., St. Louis, MO 63146. |
| NDA 019999 | Morphine Sulfate Injection (auto-injector), 10 mg/0.7 mL | Do. |
| NDA 020363 | Famvir (famciclovir) Tablets, 125 mg, 250 mg, and 500 mg | Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936-1080. |
| NDA 020711 | Zyban (bupropion hydrochloride (HCl)) Extended-Release Tablets, 100 mg, and 150 mg | GlaxoSmithKline LLC, 5 Crescent Dr., Philadelphia, PA 19112. |
| NDA 020809 | Diclofenac Sodium Ophthalmic Solution, 0.1% | Alcon Research, LLC, 6201 South Freeway, Fort Worth, TX 76134. |
| NDA 021713 | Abilify (aripiprazole) Oral Solution, 1 mg/mL | Otsuka Pharmaceutical Co., Ltd. c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. |
| NDA 021729 | Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets, 10 mg, 15 mg, 20 mg, and 30 mg | Do. |
| NDA 021866 | Abilify (aripiprazole) Injection, 9.75 mg/1.3 mL (7.5 mg/mL) | Do. |
| NDA 022024 | Actoplus Met XR (metformin HCl and pioglitazone) Extended-Release Tablets, 1gram (g)/Equivalent to (EQ) 15 mg base and 1 g/EQ 30 mg base | Takeda Pharmaceutical U.S.A. Inc., 95 Hayden Ave., Lexington, MA 02421. |
| NDA 050605 | Ceftin (cefuroxime axetil) Tablets, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base | GlaxoSmithKline Intellectual Property (no. 2) Ltd. England, c/o GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426. |
| NDA 050672 | Ceftin (cefuroxime axetil) Oral Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL | Do. |
| NDA 207988 | Zurampic (lesinurad) Tablets, 200mg | Ironwood Pharmaceuticals, Inc., 100 Summer St., Suite 2300, Boston MA 02110. |
| NDA 208383 | Bevyxxa (betrixaban) Capsules, 40 mg and 80 mg | Portola Pharmaceuticals, Inc., 270 East Grand Ave., South San Francisco, CA 94080. |
| NDA 210709 | Tekturna (aliskiren hemifumarate) Capsules (Pellets), EQ 37.5 mg base | Nodem Pharma DAC, 4820 Emperor Blvd., Durham, NC 27703. |
| NDA 210874 | Qternmet XR (dapagliflozin, metformin HCl and saxagliptin) Extended-Release Tablets, 2.5 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 | AstraZeneca AB, c/o AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803. |
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 Start Printed Page 14448that 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.
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Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
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[FR Doc. 2021-05368 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P
