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Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications

A Notice by the Food and Drug Administration on 08/04/2025

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Published Document: 2025-14683 (90 FR 36440)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2025-N-2422]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 39 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of September 3, 2025.

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, .

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(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.

Table1—NDAs for Which Approval Is Withdrawn
Application No. Drug Applicant
NDA 012674 Hexadrol (dexamethasone), Elixir, 0.5 mg/5 milliliter (mL) Aspen Global Inc., c/o Lachman Consultant Services, Inc., 1600 Stewart Ave., Westbury, NY 11590.
NDA 012675 Hexadrol (dexamethasone) Tablets, 0.5 mg, 0.75 mg, 1.5 mg, and 4 mg Do.
NDA 014694 Hexadrol (dexamethasone sodium phosphate) Injectable, Equivalent to (EQ) 4 mg phosphate/mL, EQ 10 mg phosphate/mL, and EQ 20 mg phosphate/mL Do.
NDA 016012 Vivactil (protriptyline hydrochloride (HCl)) Tablets, 5 mg and 10 mg Teva Women's Health, Inc, 145 Brandywine Parkway, West Chester, PA 19380.
NDA 016792 Surmontil (trimipramine maleate) Capsules, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base Do.
NDA 016798 Sinequan (doxepin HCl) Capsules, EQ 10 mg base, EQ 25 mg base, EQ 50 mg base, EQ 75 mg base, EQ 100 mg base, and EQ 150 mg base Pfizer Inc, 66 Hudson Blvd. East, New York, NY 10001.
NDA 017516 Sinequan (doxepin HCl) Concentrate, EQ 10 mg base/mL Do.
NDA 017525 Loxitane (loxapine succinate) Capsules, EQ 5 mg base, EQ 10 mg base, EQ 25 mg base, and EQ 50 mg base; Loxitane (loxapine succinate) Tablets, EQ 10 mg base, EQ 25 mg base, and EQ 50 mg base Teva Branded Pharmaceutical Products R&D, LLC, 145 Brandywine Parkway, West Chester, PA 19380.
NDA 017658 Loxitane C (loxapine HCl) Concentrate, EQ 25 mg base/mL Do.
NDA 017693 Drytec Technetium Tc99m Generator (technetium Tc99m sodium pertechnetate generator) Solution, 830-16600 millicurie (mCi)/generator, and 68-2703 mCi/generator GE HealthCare, 251 Locke Dr., Marlborough, MA 01752.
NDA 018110 Thallous Chloride Tl-201 (thallous chloride Tl-201) Injectable, 1 mCi/mL Do.
NDA 018920 M.V.I. Pediatric (ascorbic acid 80mg/vial; biotin 0.02 mg/vial; cyanocobalamin 0.001mg/vial; dexpanthenol 5 mg/vial; ergocalciferol 0.01mg/vial; folic acid 0.14 mg/vial; niacinamide 17 mg/vial; phytonadione 0.2 mg/vial; pyridoxine HCl 1 mg/vial; riboflavin 5′-phosphate sodium 1.4 mg/vial; thiamine HCl EQ 1.2 mg base/vial; vitamin A 0.7 mg/vial; vitamin E 7 mg/vial) For Solution Hospira, Inc., a Pfizer company, 275 North Field Drive, Lake Forest, IL 60045.
NDA 019240 E-Z Scrub 201 (povidone-iodine) Sponge, 20% Becton, Dickinson and Company, 75 N Fairway Dr., Vernon Hills, IL 60061.
NDA 019476 E-Z Scrub 241 (povidone-iodine) Sponge, 10% Do.
NDA 020551 Nimbex (cisatracurium besylate) Injectable, EQ 2 mg base/mL; Nimbex Preservative Free (cisatracurium besylate) Injectable, EQ 2 mg base/mL and EQ 10 mg base/mL AbbVie Inc., N Waukegan Rd., North Chicago, IL 60064.
NDA 020655 Alora (estradiol) Extended-release Films, 0.025 mg/24 hour, 0.05 mg/24 hour, 0.075 mg/24 hour, and 0.1 mg/24 hour Do.
NDA 020933 Viramune (nevirapine), Suspension, 50 mg/5 mL Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., Ridgefield, CT 06877-0369.
NDA 021071 Avandia (rosiglitazone maleate) Tablets, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base Woodward Pharma Services, LLC, 11705 Boyette Rd., Riverview, FL 33569.
NDA 021290 Zinecard (dexrazoxane HCl) Injectable, EQ 250 mg base/vial and EQ 500 mg base/vial Pfizer Inc.
NDA 021591 Riomet (metformin HCl) Solution, 500 mg/5 mL Ranbaxy Signature LLC c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
( printed page 36441)
NDA 021610 Opana ER (oxymorphone HCl) Extended-release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg Endo Operations Limited, c/o Endo USA, Inc., 9 Great Valley Parkway, Malvern, PA 19355.
NDA 021625 M.V.I. Adult (ascorbic acid 200 mg/vial; biotin 0.06 mg/vial; cyanocobalamin 0.005 mg/vial; dexpanthenol 15 mg/vial; ergocalciferol 0.005 mg/vial; folic acid 0.6 mg/vial; niacinamide 40 mg/vial; pyridoxine HCl 6 mg/vial; riboflavin 5′-phosphate sodium 3.6 mg/vial; thiamine HCl 6 mg/vial; Vitamin A 1 mg/vial; Vitamin E 10 mg/vial; Vitamin K 0.15 mg/vial) Injectable Hospira, Inc., a Pfizer company.
NDA 021773 Byetta (exenatide synthetic) Injectable, 300 micrograms (mcg)/1.2 mL and 600 mcg/2.4 mL AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
NDA 022107 Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, EQ 150 mg base; 12.5 mg, EQ 150 mg base; 25 mg, EQ 300 mg base; 12.5 mg, and EQ 300 mg base; 25 mg Noden Pharma DAC c/o APCER Life Sciences, 111 Town Square Place, Suite 860, Jersey City, NJ 7310.
NDA 022200 Bydureon (exenatide synthetic) For Suspension, Extended-release, 2 mg/vial; Bydureon Pen (exenatide synthetic) For Suspension, Extended-release, 2 mg AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP.
NDA 022450 Ofirmev (acetaminophen) Solution, 1000 mg/100 mL (10 mg/mL) Mallinckrodt Pharmaceuticals Ireland Limited, Mallinckrodt Hospital Products Inc., 675 James S. McDonnell Blvd., Hazelwood, MO 63042.
NDA 022519 Duexis (famotidine and ibuprofen) Tablet, 26.6 mg; 800 mg Horizon Medicines LLC, 1 Horizon Way, Deerfield, IL 60015.
NDA 050577 Zanosar (streptozocin) Injectable, 1 gram(g)/vial Teva Pharmaceuticals USA, Inc., 145 Brandywine Parkway, West Chester, PA 19380.
NDA 050693 Zithromax (azithromycin), for Suspension, EQ 1 g base/packet Pfizer Inc.
NDA 050591 Bactroban (mupirocin) Ointment, 2% SmithKlineBeecham (Cork) Ltd., Ireland c/o GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426.
NDA 050703 Bactroban (mupirocin) Nasal Ointment, 2% Do.
NDA 050746 Bactroban (mupirocin) Cream, 2% Do.
NDA 050797 Zmax (azithromycin) for Suspension, Extended-release, EQ 2 g base/bottle PF Prism C.V. c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
NDA 207986 Otiprio (ciprofloxacin) Injectable and Otic Suspension, 6% (60 mg/mL) ALK-Abelló, Inc. c/o ALK Inc., 135 Route 202/206 Suite 3, Bedminster, NJ 07921.
NDA 208653 Apadaz (acetaminophen and benzhydrocodone HCl), Tablets, 325 mg; EQ 4.08 mg base, 325 mg; EQ 6.12 mg base, and 325 mg; EQ 8.16 mg base Zevra Therapeutics, 1180 Celebration Blvd., Suite 103, Celebration, FL 34747.
NDA 209210 Bydrueon BCise (exenatide synthetic) Extended-release Suspension, 2 mg/0.85 mL AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP.
NDA 209410 Osmolex ER (amantadine HCl) Extended-release Tablets, EQ 129 mg base, EQ 161 mg base, EQ 193 mg base, and EQ 258 mg base Supernus Pharmaceuticals, Inc., 9715 Key West Ave., Rockville, MD 20850.
NDA 212895 Conjupri (levamlodipine maleate) Tablets, EQ 1.25 mg base, EQ 2.5 mg base, and EQ 5 mg base CSPC Ouyi Pharmaceutical Co., Ltd. c/o CSPC Conjupro Biotherapeutics, Inc., 302 Carnegie Center, Suite 100, Princeton, NJ 08540.
NDA 214835 Risvan (risperidone) for Suspension, Extended-release, 75 mg and 100 mg Laboratorios Farmacéuticos ROVI, S.A. c/o PharmaLex US Corporation, 1 West 1st Ave., Conshohocken, PA 19428.

Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of September 3, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA 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 September 3, 2025 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: July 30, 2025.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2025-14683 Filed 8-1-25; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2025-14683 (90 FR 36440)