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Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

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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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of September 12, 2018.

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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,

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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.

Application No.DrugApplicant
ANDA 060133Chloramphenicol Ophthalmic Ointment, 1%Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747.
ANDA 060572Mycolog 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 061107Hydrocortisone Acetate and Neomycin Sulfate Ointment, 0.5% / 0.5% and 1.5% / 0.5%Fougera Pharmaceuticals, Inc..
ANDA 061988Polycillin (ampicillin) Capsules, 250 milligrams (mg) and 500 mgBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543.
ANDA 072097Cap-Profen (ibuprofen) Tablets USP, 200 mg (White)L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010.
ANDA 072098Ibuprofen Tablets, 200 mg (Brown)  Do.
ANDA 074334Vecuronium Bromide for Injection, 10 mg/vial and 20 mg/vialWatson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 074874Pentoxifylline Extended-Release Tablets, 400 mgPliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
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ANDA 074945Atracurium Besylate Injection, 10 mg/milliliter (mL)Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 077251Finasteride Tablets USP, 5 mgGedeon Richter Plc., c/o Gedeon Richter USA, Inc., 119 Cherry Hill Rd., Suite 325, Parsippany, NJ 07054.
ANDA 077983Gemcitabine for Injection USP, Equivalent to (EQ) 200 mg base/vial and EQ 1 g/vialTeva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 080425Texacort (hydrocortisone) Topical Solution, 1%Mission Pharmacal Co., 10999 IH 10 West, Suite 1000, San Antonio, TX 78230.
ANDA 083242Amen (medroxyprogesterone acetate) Tablets, 10 mgValeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 085455Dexamethasone Tablets USP, 0.25 mgWatson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc..
ANDA 086308Homapin-10 (homatropine methylbromide) Tablets USP, 10 mgMission Pharmacal Co.
ANDA 086309Homapin-5 (homatropine methylbromide) Tablets USP, 5 mg  Do.
ANDA 086310Equipin (homatropine methylbromide) Chewable Tablets, 3 mg  Do.
ANDA 086711Beta-2 (isoetharine hydrochloride (HCl)) Inhalation Solution, 1%Nephron Pharmaceuticals, Corp., 4500 12th St. Extension, West Columbia, SC 20172.
ANDA 087438Folicet (folic acid) Tablets USP, 1 mgMission Pharmacal Co.
ANDA 087939Trimethobenzamide HCl Injection, 100 mg/mLWatson 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.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2018-17226 Filed 8-10-18; 8:45 am]