FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: SPECGX LLC; WITHDRAWAL OF APPROVAL OF ABBREVIATED NEW DRUG APPLICATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 27 MILLIGRAMS, 36 MILLIGRAMS, AND 54 MILLIGRAMS

WASHINGTON, June 18 -- Food and Drug Administration has issued a notice called: SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams.

The notice was published in the Federal Register on June 18 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) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by SpecGx LLC (SpecGx), 385 Marshall Ave, Webster Groves, MO 63119. SpecGx requested withd...