| Page Range | 40070-40071 | |
| FR Document | 2018-17226 |
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)] [Notices] [Pages 40070-40071] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17226] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2876] Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 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 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of September 12, 2018.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 060133................. Chloramphenicol Fougera Ophthalmic Pharmaceuticals, Ointment, 1%. Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. ANDA 060572................. Mycolog II (nystatin Mylan and triamcinolone Pharmaceuticals, acetonide) Ointment Inc., 781 Chestnut USP, 100,000 units/ Ridge Rd., P.O. Box gram (g) and 0.1%. 4310, Morgantown, WV 26504. ANDA 061107................. Hydrocortisone Fougera Acetate and Pharmaceuticals, Neomycin Sulfate Inc.. Ointment, 0.5%[hairsp]/ [hairsp]0.5% and 1.5%[hairsp]/ [hairsp]0.5%. ANDA 061988................. Polycillin Bristol-Myers Squibb (ampicillin) Co., P.O. Box 4000, Capsules, 250 Princeton, NJ milligrams (mg) and 08543. 500 mg. ANDA 072097................. Cap-Profen L. Perrigo Co., 515 (ibuprofen) Tablets Eastern Ave., USP, 200 mg (White). Allegan, MI 49010. ANDA 072098................. Ibuprofen Tablets, Do. 200 mg (Brown). ANDA 074334................. Vecuronium Bromide Watson Laboratories, for Injection, 10 Inc., Subsidiary of mg/vial and 20 mg/ Teva vial. Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074874................. Pentoxifylline Pliva, Inc., Extended-Release Subsidiary of Teva Tablets, 400 mg. Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. [[Page 40071]] ANDA 074945................. Atracurium Besylate Watson Laboratories, Injection, 10 mg/ Inc., Subsidiary of milliliter (mL). Teva Pharmaceuticals USA, Inc. ANDA 077251................. Finasteride Tablets Gedeon Richter Plc., USP, 5 mg. c/o Gedeon Richter USA, Inc., 119 Cherry Hill Rd., Suite 325, Parsippany, NJ 07054. ANDA 077983................. Gemcitabine for Teva Pharmaceuticals Injection USP, USA, Inc., 425 Equivalent to (EQ) Privet Rd., 200 mg base/vial Horsham, PA 19044. and EQ 1 g/vial. ANDA 080425................. Texacort Mission Pharmacal (hydrocortisone) Co., 10999 IH 10 Topical Solution, West, Suite 1000, 1%. San Antonio, TX 78230. ANDA 083242................. Amen Valeant (medroxyprogesteron Pharmaceuticals e acetate) Tablets, North America, LLC, 10 mg. 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. ANDA 085455................. Dexamethasone Watson Laboratories, Tablets USP, 0.25 Inc., Subsidiary of mg. Teva Pharmaceuticals USA, Inc.. ANDA 086308................. Homapin-10 Mission Pharmacal (homatropine Co. methylbromide) Tablets USP, 10 mg. ANDA 086309................. Homapin-5 Do. (homatropine methylbromide) Tablets USP, 5 mg. ANDA 086310................. Equipin (homatropine Do. methylbromide) Chewable Tablets, 3 mg. ANDA 086711................. Beta-2 (isoetharine Nephron hydrochloride Pharmaceuticals, (HCl)) Inhalation Corp., 4500 12th Solution, 1%. St. Extension, West Columbia, SC 20172. ANDA 087438................. Folicet (folic acid) Mission Pharmacal Tablets USP, 1 mg. Co. ANDA 087939................. Trimethobenzamide Watson Laboratories, HCl Injection, 100 Inc., Subsidiary of mg/mL. 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. Dated: August 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17226 Filed 8-10-18; 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 September 12, 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 40070 |