FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC., ET AL.; WITHDRAWAL OF APPROVAL OF 39 NEW DRUG APPLICATIONS

WASHINGTON, Aug. 4 -- Food and Drug Administration has issued a notice called: Teva Branded Pharmaceutical Products R&D, Inc, et al.; Withdrawal of Approval of 39 New Drug Applications.

The notice was published in the Federal Register on Aug. 4 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 39 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

For more information, contact Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Admi...