[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47566-47567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2462]
Pfizer, Inc., et al.; Withdrawal of Approval of 23 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 23 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applications be withdrawn.
DATES: Approval is withdrawn as of July 3, 2024.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.
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Table 1--NDAs for Which Approval Is Withdrawn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 012427............. Didrex (benzfetamine Pfizer, Inc., 66
hydrogen chloride Hudson Boulevard
(HCl)) Tablets, 25 East, New York, NY
milligrams (mg) and 50 10001.
mg.
NDA 016131............. Clomid (clomiphene Sanofi US Services
citrate) Tablets, 50 Inc., C/O Sanofi-
mg. Aventis U.S. LLC, 55
Corporate Dr.,
Bridgewater, NJ
08807.
NDA 016584............. Navane (thiothixene Do.
HCl) Capsules, 1 mg, 2
mg, 5 mg, 10 mg, and
20 mg.
NDA 019032............. Tenex (guanfacine HCl) Promius Pharma, LLC, C/
Tablets, 1 mg, 2 mg, O Dr. Reddy's
and 3 mg. Laboratories Inc.,
107 College Rd. East,
Princeton, NJ 08540.
NDA 019776............. Concentraid Ferring
(desmopressin acetate) Pharmaceuticals Inc.,
Nasal Solution, 0.01%. 100 Interpace
Parkway, Parsippany,
NJ 07054.
[[Page 47567]]
NDA 019826............. Theophylline and B. Braun Medical Inc,
Dextrose 5% Injections 901 Marcon Blvd.,
in Plastic Container, Allentown, PA 18109.
40 mg/100 milliliters
(mL), 80 mg/100 mL,
160 mg/100 mL, 200 mg/
100 mL, 320 mg/100 mL,
and 400 mg/100 mL.
NDA 020659............. Norvir (ritonavir) Oral AbbVie Inc. 1 N.
Solution, 80 mg/mL. Waugekan Rd., North
Chicago, IL 60064.
NDA 020706............. Emadine (emedastine Novartis
difumarate) Ophthalmic Pharmaceuticals Co.,
Solution, 0.05%. 1 Health Plaza, East
Hanover, NJ 07936-
1080
NDA 020884............. Aggrenox (aspirin and Boehringer Ingelheim
dipyridamole) Extended- Pharmaceuticals,
Release Capsules, 25 Inc., 900 Ridgebury
mg/200 mg. Rd, Ridgefield, CT
06877.
NDA 020928............. Glucagon Injection, 1 Eli Lilly and Company,
mg/vial. Lilly Corporate
Center, Indianapolis,
IN 46285.
NDA 020972............. Sustiva (efavirenz) Bristol-Myers Squibb
Capsules, 50 mg, 100 Company, P.O. Box
mg, and 200 mg. 4000, Princeton, NJ
08543-4000.
NDA 021400............. Levitra (vardenafil Bayer HealthCare
HCI) Tablets, 2.5 mg, Pharmaceuticals Inc.
5 mg, 10 mg, and 20 mg.
NDA 021449............. Hepsera (adefovir Gilead Sciences, Inc.,
dipivoxil) Tablets, 10 333 Lakeside Dr.,
mg. Foster City, CA
94404.
NDA 021623............. Synera (lidocaine and Galen Specialty Pharma
tetracaine) Patch, 70 US, LLC, 25 Fretz
mg/70 mg. Rd., Souderton, PA
18694.
NDA 022331............. Kapvay (clonidine HCl) Concordia
Extended-Release Pharmaceuticals, Inc
Tablets, 0.1 mg and C/O Cardinal Health
0.2 mg. Reg Sciences, 7400
Jenloga (clonidine HCl) West 110th St., Suite
Extended-Release 150, Overland Park,
Tablets, 0.1 mg and KS 66210.
0.2 mg.
NDA 022343............. Efavirenz, Lamivudine Aurobindo Pharma
and Tenofovir Limited C/O Aurobindo
Disoproxil Fumarate Pharma USA, Inc., 279
Tablets, 600 mg/300 mg/ Princeton-Highstown
300 mg. Rd., East Windsor, NJ
08520.
NDA 022344............. Lamivudine and Do.
Tenofovir Disoproxil
Fumarate Tablets, 300
mg/300 mg.
NDA 200179............. Staxyn (vardenafil HCl) Bayer HealthCare
Orally Disintegrating Pharmaceuticals, Inc.
Tablets, 10 mg.
NDA 200671............. Durlaza (aspirin) HESP LLC, 312
Extended-Release Farmington Ave.,
Capsules, 162.5 mg. Farmington, CT 06032.
NDA 202158............. Radiogenix System NorthStar Medical
(technetium Tc-99m Radioisotopes, LLC,
generator) For the 1800 Gateway Blvd.,
Production of Sodium Beloit, WI 53511.
Pertechnetate Tc 99m
Injection,
Intravenous,
Intravesicular, and
Ophthalmic Solution,
30-1153 millicurie/
Generator.
NDA 205004............. Bortezomib Powder for Fresenius Kabi USA,
Injection, 3.5 mg/vial. LLC, 3 Corporate Dr.,
Lake Zurich, IL
60047.
NDA 205787............. Evzio (naloxone HCl) Kaleo, Inc., 111
Solution for Virginia St., Suite
Injection, 0.4 mg/0.4 300, Richmond, VA
mL. 23219.
NDA 209862............. Evzio (naloxone HCl) Do.
Auto-Injector for
Injection, 2 mg/0.4 mL.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of July 3,
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 new drug application 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 3, 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: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12065 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P