Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of July 11, 2019.
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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 applicants 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 070185||Fluor-Op (fluorometholone) Ophthalmic Suspension, 0.1%||Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936.|
|ANDA 070858||Trazodone Hydrochloride Tablets USP, 100 milligrams (mg)||Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.|
|ANDA 076023||Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg||Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.|
|ANDA 078167||Paclitaxel Injection USP, 6 mg/milliliter||Sandoz, Inc., 100 College Rd. West, Princeton, NJ 08540.|
|ANDA 088726||Chlorpropamide Tablets USP, 250 mg||Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520.|
|ANDA 089852||Chlorzoxazone Tablets USP, 250 mg||Do.|
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 11, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. 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 July 11, 2019 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12287 Filed 6-10-19; 8:45 am]
BILLING CODE 4164-01-P