Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of September 12, 2018.
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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, Trang.Tran@fda.hhs.gov.
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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 § 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.
|ANDA 060133||Chloramphenicol Ophthalmic Ointment, 1%||Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747.|
|ANDA 060572||Mycolog II (nystatin and triamcinolone acetonide) Ointment USP, 100,000 units/gram (g) and 0.1%||Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.|
|ANDA 061107||Hydrocortisone Acetate and Neomycin Sulfate Ointment, 0.5% / 0.5% and 1.5% / 0.5%||Fougera Pharmaceuticals, Inc..|
|ANDA 061988||Polycillin (ampicillin) Capsules, 250 milligrams (mg) and 500 mg||Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543.|
|ANDA 072097||Cap-Profen (ibuprofen) Tablets USP, 200 mg (White)||L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010.|
|ANDA 072098||Ibuprofen Tablets, 200 mg (Brown)|| Do.|
|ANDA 074334||Vecuronium Bromide for Injection, 10 mg/vial and 20 mg/vial||Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.|
|ANDA 074874||Pentoxifylline Extended-Release Tablets, 400 mg||Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.|
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|ANDA 074945||Atracurium Besylate Injection, 10 mg/milliliter (mL)||Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.|
|ANDA 077251||Finasteride Tablets USP, 5 mg||Gedeon Richter Plc., c/o Gedeon Richter USA, Inc., 119 Cherry Hill Rd., Suite 325, Parsippany, NJ 07054.|
|ANDA 077983||Gemcitabine for Injection USP, Equivalent to (EQ) 200 mg base/vial and EQ 1 g/vial||Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.|
|ANDA 080425||Texacort (hydrocortisone) Topical Solution, 1%||Mission Pharmacal Co., 10999 IH 10 West, Suite 1000, San Antonio, TX 78230.|
|ANDA 083242||Amen (medroxyprogesterone acetate) Tablets, 10 mg||Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.|
|ANDA 085455||Dexamethasone Tablets USP, 0.25 mg||Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc..|
|ANDA 086308||Homapin-10 (homatropine methylbromide) Tablets USP, 10 mg||Mission Pharmacal Co.|
|ANDA 086309||Homapin-5 (homatropine methylbromide) Tablets USP, 5 mg|| Do.|
|ANDA 086310||Equipin (homatropine methylbromide) Chewable Tablets, 3 mg|| Do.|
|ANDA 086711||Beta-2 (isoetharine hydrochloride (HCl)) Inhalation Solution, 1%||Nephron Pharmaceuticals, Corp., 4500 12th St. Extension, West Columbia, SC 20172.|
|ANDA 087438||Folicet (folic acid) Tablets USP, 1 mg||Mission Pharmacal Co.|
|ANDA 087939||Trimethobenzamide HCl Injection, 100 mg/mL||Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.|
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of September 12, 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 September 12, 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.
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Dated: August 7, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-17226 Filed 8-10-18; 8:45 am]
BILLING CODE 4164-01-P