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[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Pages 91410-91412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26913]

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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.

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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applications be withdrawn.

DATES: Approval is withdrawn as of December 19, 2024.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, [email protected].

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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

              Table 1--NDAs for Which Approval Is Withdrawn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

    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]
BILLING CODE 4164-01-P
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