FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PAR HEALTH USA LLC, U.S. AGENT FOR PH HEALTH LIMITED, ET AL.; WITHDRAWAL OF APPROVAL OF 37 ABBREVIATED NEW DRUG APPLICATIONS

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications.

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 37 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

For more information, contact Martha Nguyen, Center for Drug Evaluation and ...