Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-5851]</DEPDOC> <SUBJECT>Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Approval is withdrawn as of February 14, 2025. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">Kimberly.Lehrfeld@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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. <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="xs68,r100,r100"> <TTITLE>Table 1—NDAs for Which Approval Is Withdrawn</TTITLE> <CHED H="1">Application No.</CHED> <CHED H="1">Drug</CHED> <CHED H="1">Applicant</CHED> <ROW> <ENT I="01">NDA 009388</ENT> <ENT>Diamox IV (acetazolamide) Injectable, Equivalent to (EQ) 500 milligrams (mg) base per vial</ENT> <ENT>Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Parkway, West Chester, PA 19380.</ENT> </ROW> <ROW> <ENT I="01">NDA 012836</ENT> <ENT>Persantine (dipyridamole) Tablets, 25mg, 50mg, and 75mg</ENT> <ENT>Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877.</ENT> </ROW> <ROW> <ENT I="01">NDA 018817</ENT> <ENT>Calan (verapamil hydrochloride (HCl)) Tablets, 40 mg, 80 mg, 120 mg, and 160 mg</ENT> <ENT>Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001.</ENT> </ROW> <ROW> <ENT I="01">NDA 021743</ENT> <ENT>Tarceva (erlotinib HCl) Tablets, EQ 25 mg base, EQ 100 mg base, and EQ 150 mg base</ENT> <ENT>OSI Pharmaceuticals, LLC, 2375 Waterview Dr., Northbrook, IL 60062.</ENT> </ROW> <ROW> <ENT I="01">NDA 021785</ENT> <ENT>Invirase (saquinavir mesylate) Tablets, EQ 500 mg base</ENT> <ENT>Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080.</ENT> </ROW> <ROW> <ENT I="01">NDA 021937</ENT> <ENT>Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Tablets, 600 mg/200 mg/300 mg</ENT> <ENT>Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.</ENT> </ROW> <ROW> <ENT I="01">NDA 022383</ENT> <ENT>Arcapta Neohaler (indacaterol maleate) Powder for Inhalation, EQ 75 micrograms base</ENT> <ENT>Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.</ENT> </ROW> <ROW> <ENT I="01">NDA 204412</ENT> <ENT>Delzicol (mesalamine), Delayed-Release Capsules, 400 mg</ENT> <ENT>AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064.</ENT> </ROW> <ROW> <ENT I="01">NDA 210875</ENT> <ENT>Kynmobi (apomorphine HCl) Sublingual Film, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg</ENT> <ENT>Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752.</ENT> </ROW> <ROW> <ENT I="01">NDA 211172</ENT> <ENT>Tegsedi (inotersen sodium) Solution for Injection, EQ 284 mg base/1.5 mL</ENT> <ENT>Akcea Therapeutics, Inc., 2850 Gazelle Ct., Carlsbad, CA 92010.</ENT> </ROW> <ROW> <ENT I="01">NDA 212640</ENT> <ENT>Exservan (riluzole) Oral Film, 50 mg</ENT> <ENT>Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 07059.</ENT> </ROW> <ROW> <ENT I="01">NDA 213426</ENT> <ENT>Seglentis (celecoxib and tramadol HCl) 56 mg; 44 mg</ENT> <ENT>Kowa Pharmaceuticals America, Inc., 530 Industrial Park Blvd., Montgomery, AL 36117.</ENT> </ROW> </GPOTABLE> 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. <SIG> <DATED>Dated: January 6, 2025.</DATED> <NAME>P. Ritu Nalubola,</NAME> Associate Commissioner for Policy. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-00743 Filed 1-14-25; 8:45 am]</FRDOC> </NOTICE>