WASHINGTON, Dec. 12 -- Food and Drug Administration has issued a notice called: Pfizer Inc, U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications.
The notice was published in the Federal Register on Dec. 12 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Evaluati...