FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TEVA PHARMACEUTICALS USA, INC., ET AL.; WITHDRAWAL OF APPROVAL OF 23 ABBREVIATED NEW DRUG APPLICATIONS; CORRECTION

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Teva Pharmaceuticals USA, Inc, et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction.

The notice was published in the Federal Register on April 9 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Registeron January 15, 2025. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 209325 for miglustat capsule, 100 milligrams, held by Breckenridge Pharmaceutica...