[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applications be withdrawn.
DATES: Approval is withdrawn as of December 19, 2024.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Table 1--NDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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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.
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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