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Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Ag...

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Department of Health and Human Services

Food and Drug Administration

[Docket No. FDA-2024-N-2803]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of July 22, 2024.

FOR FURTHER INFORMATION CONTACT:

Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-3471, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

The applicants listed in table 1 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© (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. ( printed page 52058)

Table—ANDAs for Which Approval Is Withdrawn
Application No.	Drug	Applicant
ANDA 040118	Carisoprodol, Aspirin and Codeine Phosphate Tablets, 325 milligrams (mg), 200 mg, and 16 mg	Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540.
ANDA 040291	Fluorouracil Injection, 50 mg/milliliters (mL)	Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 071849	Morphine Sulfate Injectable, 0.5 mg/mL	Hospira, Inc., 275 North Field Dr., Building H1-3S, Lake Forest, IL 60045.
ANDA 074133	Metoprolol Tartrate Injectable, 1 mg/mL	Do.
ANDA 076648	Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, 75 mg, and 25 mg	Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520.
ANDA 077387	Ondansetron Hydrochloride (HCl) Preservative Free Injection, Equivalent to (EQ) 2 mg base/mL	American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
ANDA 077582	Ondansetron HCl Injectable, EQ 2 mg base/mL	Do.
ANDA 079039	Ondansetron HCl Injection, EQ 2 mg base/mL	Do.
ANDA 087440	Dexamethasone Sodium Phosphate Injection, EQ 4 mg phosphate/mL	Do.
ANDA 088388	Mepivacaine HCl and Levonordefrin Injection, 0.05 mg/mL; 2%	ICON Clinical Research, LLC, U.S. Agent for Deproco, Inc., 4130 ParkLake Ave., Suite 400, Raleigh, NC 27612.
ANDA 090578	Ampicillin and Sulbactam For Injection, EQ 10 grams(g) base/vial and EQ 5 grams (g) base/vial	EAS Consulting Group, LLC, U.S. Agent for Astral SteriTech Pvt. Ltd., 1700 Diagonal Rd., #750, Alexandria, VA 22314.
ANDA 090579	Ampicillin and Sulbactam For Injection, EQ 1 g base/vial, EQ 500 mg base/vial, EQ 2 g base/vial, and EQ 1 g base/vial	Do.
ANDA 090723	Duloxetine HCl Capsules, Delayed-Release Pellets, EQ 20 mg base, EQ 30 mg base, and EQ 60 mg base	Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788.
ANDA 207266	Bupivacaine HCl Injectable, 0.75%	Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015.
ANDA 207794	Busulfan Injection, 6 mg/mL	Nexus Pharmaceuticals, Inc., 400 Knightsbridge Pkwy., Lincolnshire, IL 60069.
ANDA 209068	Chlorthalidone Tablets, 25 mg and 50 mg	Elity LLC, U.S. Agent for Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke Pines, FL 33027.
ANDA 212223	Captopril Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg	Pharmobedient Consulting, LLC, U.S. Agent for Seton Pharmaceuticals, LLC, 642 North East 3rd Ave., Fort Lauderdale, FL 33304.
ANDA 212287	Piperacillin and Tazobactam For Injection, EQ 2 g base/vial, EQ 250 mg base/vial, EQ 3 g base/vial, EQ 375 mg base/vial, EQ 4 g base/vial, and EQ 500 mg base/vial	EAS Consulting Group, LLC.
ANDA 212721	Cefepime HCl For Injection, EQ 1 g base/vial and EQ 2 g base/vial	Do.
ANDA 213552	Succinylcholine Chloride Injection, 20 mg/mL	Nexus Pharmaceuticals, Inc.

Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of July 22, 2024. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application or ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on July 22, 2024 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: June 17, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2024-13660 Filed 6-20-24; 8:45 am]

BILLING CODE 4164-01-P

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89 FR 52057

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“Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications,” thefederalregister.org (June 21, 2024), https://thefederalregister.org/documents/2024-13660/sandoz-inc-et-al-withdrawal-of-approval-of-20-abbreviated-new-drug-applications.