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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-5851]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of February 14, 2025.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, 
                        *Kimberly.Lehrfeld@fda.hhs.gov.*


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 § 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 § 314.150(c) is without prejudice to refiling. Table 1—NDAs for Which Approval Is Withdrawn
Application No.
Drug
ApplicantNDA 009388
Diamox IV (acetazolamide) Injectable, Equivalent to (EQ) 500 milligrams (mg) base per vial
Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Parkway, West Chester, PA 19380.NDA 012836
Persantine (dipyridamole) Tablets, 25mg, 50mg, and 75mg
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877.NDA 018817
Calan (verapamil hydrochloride (HCl)) Tablets, 40 mg, 80 mg, 120 mg, and 160 mg
Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001.NDA 021743
Tarceva (erlotinib HCl) Tablets, EQ 25 mg base, EQ 100 mg base, and EQ 150 mg base
OSI Pharmaceuticals, LLC, 2375 Waterview Dr., Northbrook, IL 60062.NDA 021785
Invirase (saquinavir mesylate) Tablets, EQ 500 mg base
Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080.NDA 021937
Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Tablets, 600 mg/200 mg/300 mg
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.NDA 022383
Arcapta Neohaler (indacaterol maleate) Powder for Inhalation, EQ 75 micrograms base
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.NDA 204412
Delzicol (mesalamine), Delayed-Release Capsules, 400 mg
AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064.NDA 210875
Kynmobi (apomorphine HCl) Sublingual Film, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg
Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752.( print page 3878)NDA 211172
Tegsedi (inotersen sodium) Solution for Injection, EQ 284 mg base/1.5 mL
Akcea Therapeutics, Inc., 2850 Gazelle Ct., Carlsbad, CA 92010.NDA 212640
Exservan (riluzole) Oral Film, 50 mg
Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 07059.NDA 213426
Seglentis (celecoxib and tramadol HCl) 56 mg; 44 mg
Kowa Pharmaceuticals America, Inc., 530 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