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89 FR 223 pgs. 91410-91412 - Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications

Type: NOTICEVolume: 89Number: 223Pages: 91410 - 91412
Docket number: [Docket No. FDA-2024-N-4860]
FR document: [FR Doc. 2024-26913 Filed 11-18-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 91410, 91411, 91412

[top] page 91410

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4860]

Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 26 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of December 19, 2024.

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:


[top] 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. page 91411 Withdrawal of approval of an application or abbreviated application under §?314.150(c) is without prejudice to refiling.

Application No. Drug Applicant
NDA 012541 Depo-Provera (medroxyprogesterone acetate) Injectable, 100 milligrams (mg)/milliliter (mL) and 400 mg/mL Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
NDA 012945 Diamox (acetazolamide) Extended-Release Capsules, 500 mg Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Parkway, West Chester, PA 19380.
NDA 013132 Deca-Durabolin (nandrolone decanoate) Injectable, 50 mg/mL,100 mg/mL, and 200 mg/mL Woodward Specialty, LLC, 16825 West 116th St., Lenexa, KS 66219.
NDA 018063 Corgard (nadolol) Tablets, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg USWM, LLC, 4441 Springdale Rd., Louisville, KY 40241.
NDA 019950 Diflucan in Dextrose 5% in Plastic Container (fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 mL Diflucan in Sodium Chloride 0.9% (fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 mL Diflucan in Sodium Chloride 0.9% in Plastic Container (fluconazole), Injectable, 200 mg/100 mL and 400 mg/200 mL Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
NDA 020001 Capex (fluocinolone acetonide) Shampoo, 0.01% Galderma Laboratories, L.P., 2001 Ross Ave., Suite 1600, Dallas, TX 75201.
NDA 020938 Mobic (meloxicam) Tablets, 7.5 mg and 15 mg Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., Ridgefield, CT 06877.
NDA 021333 Minirin (desmopressin acetate) Metered Nasal Spray, 0.01 mg/spray Ferring Pharmaceuticals Inc., 100 Interpace Parkway, Parsippany, NJ 07054.
NDA 021372 Aloxi (palonosetron hydrochloride (HCl)) Injectable, Equivalent to (EQ) 0.075 mg base/1.5 mL and EQ 0.25 mg base/5 mL Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc., 200 Wood Ave. South, Suite 100, Iselin, New Jersey 08830.
NDA 021689 Nexium IV (esomeprazole sodium) Injectable, EQ 20 mg base/vial and EQ 40mg base/vial AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
NDA 021861 Patanase (olopatadine HCl) Metered Nasal Spray, 0.665 mg/spray Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
NDA 022025 Totect (dexrazoxane HCl) Injectable, EQ 500 mg base/vial Clinigen, Inc., 45 Great Valley Parkway, Malvern, PA 19355.
NDA 022204 Gelnique (oxybutynin chloride) Transdermal Gel, 10% (100 mg/packet) AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
NDA 022233 Aloxi (palonosetron HCl) Capsules, EQ 0.5 mg base Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc.
NDA 022502 Differin (adapalene) Lotion, 0.1% Galderma Laboratories.
NDA 022524 Zuplenz (ondansetron) Oral Film, 4 mg and 8 mg Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 07059.
NDA 050297 Ery-Ped (erythromycin ethylsuccinate) Chewable Tablets, EQ 200 mg base E.E.S. (erythromycin ethylsuccinate) Chewable Tablets, EQ 200 mg base Azurity Pharmaceuticals, Inc., 8 Cabot Rd., Woburn, MA 01801.
NDA 050611 PCE (erythromycin) Coated Particles in Tablets, 333 mg and 500 mg Do.
NDA 050824 Omeclamox-Pak (amoxicillin Capsules, 500 mg; clarithromycin Tablets, 500 mg; and omeprazole Delayed-Release Capsules, 20 mg) Cumberland Pharmaceuticals Inc., 1600 West End Ave., Suite 1300, Nashville, TN 37203.
NDA 203667 Minastrin 24 Fe (ethinyl estradiol/norethindrone acetate) Tablets, 0.02 mg/1 mg Allergan Pharmaceuticals International Ltd. c/o AbbVie Inc., 1 N Waukegan Rd., North Chicago, IL 60064.
NDA 204427 Kerydin (tavabarole) Topical Solution, 5% Anacor Pharmaceuticals Inc., 445 Eastern Point Rd., Groton, CT 06340.
NDA 205103 Yosprala (aspirin/omeprazole) Delayed-Release Tablets, 81 mg/40 mg and 325 mg/40 mg Genus Lifesciences Inc., 514 North 12th St., Allentown, PA 18102.
NDA 205383 Oraltag (iohexol) for Oral Solution, 9.7 gram/bottle Interpharma Praha AS c/o Otsuka Pharmaceutical Development and Commercialization Inc., 508 Carnegie Center Dr., Princeton, NJ 08540.
NDA 207930 Utibron (glycopyrrolate, indacaterol maleate) Inhalation Powder, 15.6 microgram/inhaler and 27.5 microgram/inhaler Novartis Pharmaceuticals Corp.
NDA 207923 Seebri Neohaler (glycopyrrolate) Inhalation Powder, 15.6 microgram/inhaler Do.
NDA 216951 Jesduvroq (daprodustat) Tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg GlaxoSmithKline Intellectual Property (No. 2) Ltd. England c/o GSK, 2929 Walnut St., Suite 1700, Philadelphia, PA 19104.


[top] Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of December 19, 2024. 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 page 91412 are listed in table 1 that are in inventory on December 19, 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: November 7, 2024.

Kimberlee Trzeciak,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2024-26913 Filed 11-18-24; 8:45 am]

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