| Page Range | 35654-35655 | |
| FR Document | 2018-16037 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35654-35655] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16037] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2493] ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of August 27, 2018. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected]. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described 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. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 020345............ Aminosyn-HF (amino ICU Medical, Inc., 600 acids) Injection, 8%. North Field Dr., Lake Forest, IL 60045. ANDA 040723............ Isosorbide Dinitrate Impax Laboratories, Extended-Release Inc., 30831 Huntwood Tablets USP, 40 Ave., Hayward, CA milligrams (mg). 94544. ANDA 064062............ Amphotericin B for Teva Parenteral Injection USP, 50 mg/ Medicines, Inc., 19 vial. Hughes, Irvine, CA 92618. ANDA 064200............ Cefotaxime for Fresenius Kabi USA, Injection USP, LLC, Three Corporate Equivalent to (EQ) 500 Dr., Lake Zurich, IL mg base/vial, EQ 1 60047. gram (g) base/vial, and EQ 2 g base/vial. [[Page 35655]] ANDA 064201............ Cefotaxime for Do. Injection USP, EQ 10 g base/vial and EQ 20 g base/vial. ANDA 065251............ Cefuroxime for Samson Medical Injection USP, EQ 75 g Technologies, LLC, base/bag and EQ 225 g 2050 Springdale Rd., base/bag (Pharmacy P.O. Box 2730, Suite Bulk Package). 400, Cherry Hill, NJ 08034. ANDA 070892............ Metoclopramide Norbrook Laboratories, Hydrochloride (HCl) Ltd., c/o Norbrook, Injection, EQ 10 mg Inc., 9401 Indian base/2 milliliters Creek Pkwy., Suite (mL). 680, Overland Park, KS 66210. ANDA 075309............ Ticlopidine HCl Tablets Watson Laboratories, USP, 250 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 076797............ Risperidone Oral Precision Dose, Inc., Solution USP, 1 mg/mL. 722 Progressive Lane, South Beloit, IL 61080. ANDA 077656............ Thrive (nicotine GlaxoSmithKline polacrilex) Gum USP Consumer Healthcare, (Chewable), EQ 4 mg 184 Liberty Corner base. Rd., Suite 200, Warren, NJ 07059. ANDA 077658............ Thrive (nicotine Do. polacrilex) Gum USP (Chewable), EQ 2 mg base. ANDA 080188............ Testosterone Propionate Watson Laboratories, Injection USP, 25 mg/ Inc., Subsidiary of mL, 50 mg/mL, and 100 Teva Pharmaceuticals mg/mL. USA, Inc. ANDA 083398............ Prednisolone Acetate Do. Injectable Suspension, 25 mg/mL. ANDA 083764............ Prednisolone Acetate Do. Injectable Suspension, 50 mg/mL. ANDA 084072............ Triamcinolone Diacetate Do. Injection, 40 mg/mL. ANDA 084270............ Triamcinolone Tablets Do. USP, 4 mg. ANDA 084466............ Reserpine and Do. Hydrochlorothiazide Tablets, 0.125 mg/25 mg. ANDA 084604............ Procainamide HCl Ivax Pharmaceuticals, Capsules, 250 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 085693............ Phentermine HCl Tablets Sandoz, Inc., 4700 USP, 8 mg. Sandoz Dr., Wilson, NC 27893. ANDA 085863............ Theophylline Elixir, 80 Precision Dose, Inc. mg/15 mL. ANDA 087185............ Ergoloid Mesylates Ivax Pharmaceuticals, Sublingual Tablets Inc., Subsidiary of USP, 1 mg. Teva Pharmaceuticals USA, Inc. ANDA 087770............ Sulfinpyrazone Capsules Do. USP, 200 mg. ANDA 088648............ Methotrexate Injection Norbrook Laboratories, USP, EQ 25 mg base/mL. Ltd., c/o Norbrook, Inc. ANDA 088928............ Chlorzoxazone Tablets Actavis Elizabeth, USP, 250 mg. LLC, Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 090663............ Gemcitabine for Hameln RDS GmbH, c/o Injection USP, EQ 200 B&H Consulting mg base/vial and EQ 1 Services, Inc., 50 g base/vial. Division St., Suite 206, Somerville, NJ 08876. ANDA 091469............ Vancomycin HCl for Mylan Laboratories, Injection USP, EQ 10 g Ltd., c/o Mylan base/vial (Pharmacy Pharmaceuticals, Bulk Package). Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. ANDA 202390............ Tramadol HCl Tablets Accord Healthcare, USP, 50 mg. Inc., 1009 Slater Rd., Suite 210-B, Durham, NC 27703. ANDA 203506............ Oxymorphone HCl Sun Pharmaceutical Extended-Release Industries, Ltd., c/o Tablets, 5 mg, 7.5 mg, Sun Pharmaceutical 10 mg, 15 mg, 20 mg, Industries, Inc., 2 30 mg, and 40 mg. Independence Way, Princeton, NJ 08540. ANDA 204320............ Olanzapine Orally Ajanta Pharma, Ltd., c/ Disintegrating Tablets o Ajanta Pharma USA, USP, 5 mg, 10 mg, 15 Inc., 440 U.S. mg, and 20 mg. Highway 22 East, One Grande Commons, Suite 150, Bridgewater, NJ 08807. ANDA 204706............ Olopatadine HCl Zambon S.p.A., c/o Ophthalmic Solution Camargo USP, EQ 0.1% base. Pharmaceutical Services, LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242. ANDA 207467............ Nevirapine Extended- Technology Organized, Release Tablets, 100 LLC, 9191 Point mg and 400 mg. Replete Dr., Fort Belvoir, VA 22060. ------------------------------------------------------------------------ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 27, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on August 27, 2018 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: July 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16037 Filed 7-26-18; 8:45 am] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of August 27, 2018. | |
| Contact | Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected] | |
| FR Citation | 83 FR 35654 |