FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AMNEAL PHARMACEUTICALS OF NEW YORK, LLC; WITHDRAWAL OF APPROVAL OF ABBREVIATED NEW DRUG APPLICATION FOR CELECOXIB CAPSULES, 50 MILLIGRAMS, 100 MILLIGRAMS, 200 MILLIGRAMS, AND 400 MILLIGRAMS

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams.

The notice was published in the Federal Register on Oct. 9 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd, Brookhaven, NY 11719 (Amneal). Amneal requested withdraw...