[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applications be withdrawn.
DATES: Approval is withdrawn as of February 14, 2025.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Table 1--NDAs for Which Approval Is Withdrawn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.
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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