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[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3877-3878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00743]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5851]

Teva Branded Pharmaceutical Products R&D, Inc., et al.; 
Withdrawal of Approval of 12 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 12 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applications be withdrawn.

DATES: Approval is withdrawn as of February 14, 2025.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, [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              Table 1--NDAs for Which Approval Is Withdrawn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 009388..............  Diamox IV               Teva Branded
                           (acetazolamide)         Pharmaceutical
                           Injectable,             Products R&D, Inc.,
                           Equivalent to (EQ)      145 Brandywine
                           500 milligrams (mg)     Parkway, West
                           base per vial.          Chester, PA 19380.
NDA 012836..............  Persantine              Boehringer Ingelheim
                           (dipyridamole)          Pharmaceuticals,
                           Tablets, 25mg, 50mg,    Inc., 900 Ridgebury
                           and 75mg.               Road, P.O. Box 368,
                                                   Ridgefield, CT 06877.
NDA 018817..............  Calan (verapamil        Pfizer Inc., 66 Hudson
                           hydrochloride (HCl))    Boulevard East, New
                           Tablets, 40 mg, 80      York, NY 10001.
                           mg, 120 mg, and 160
                           mg.
NDA 021743..............  Tarceva (erlotinib      OSI Pharmaceuticals,
                           HCl) Tablets, EQ 25     LLC, 2375 Waterview
                           mg base, EQ 100 mg      Dr., Northbrook, IL
                           base, and EQ 150 mg     60062.
                           base.
NDA 021785..............  Invirase (saquinavir    Hoffmann-La Roche,
                           mesylate) Tablets, EQ   Inc. c/o Genentech,
                           500 mg base.            Inc., 1 DNA Way,
                                                   South San Francisco,
                                                   CA 94080.
NDA 021937..............  Atripla (efavirenz,     Gilead Sciences, Inc.,
                           emtricitabine, and      333 Lakeside Dr.,
                           tenofovir disoproxil    Foster City, CA
                           fumarate) Tablets,      94404.
                           600 mg/200 mg/300 mg.
NDA 022383..............  Arcapta Neohaler        Novartis
                           (indacaterol maleate)   Pharmaceuticals
                           Powder for              Corp., 1 Health
                           Inhalation, EQ 75       Plaza, East Hanover,
                           micrograms base.        NJ 07936.
NDA 204412..............  Delzicol (mesalamine),  AbbVie Inc., 1 N.
                           Delayed-Release         Waukegan Rd., North
                           Capsules, 400 mg.       Chicago, IL 60064.
NDA 210875..............  Kynmobi (apomorphine    Sumitomo Pharma
                           HCl) Sublingual Film,   America, Inc., 84
                           10 mg, 15 mg, 20 mg,    Waterford Dr.,
                           25 mg, and 30 mg.       Marlborough, MA
                                                   01752.

[[Page 3878]]

 
NDA 211172..............  Tegsedi (inotersen      Akcea Therapeutics,
                           sodium) Solution for    Inc., 2850 Gazelle
                           Injection, EQ 284 mg    Ct., Carlsbad, CA
                           base/1.5 mL.            92010.
NDA 212640..............  Exservan (riluzole)     Aquestive
                           Oral Film, 50 mg.       Therapeutics, 30
                                                   Technology Dr.,
                                                   Warren, NJ 07059.
NDA 213426..............  Seglentis (celecoxib    Kowa Pharmaceuticals
                           and tramadol HCl) 56    America, Inc., 530
                           mg; 44 mg.              Industrial Park
                                                   Blvd., Montgomery, AL
                                                   36117.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn as of February 
14, 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 
February 14, 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: January 6, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00743 Filed 1-14-25; 8:45 am]
BILLING CODE 4164-01-P
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