FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: EGIS PHARMACEUTICALS LIMITED, ET AL.; WITHDRAWAL OF APPROVAL OF THREE ABBREVIATED NEW DRUG APPLICATIONS

WASHINGTON, April 24 -- Food and Drug Administration has issued a notice called: Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications.

The notice was published in the Federal Register on April 24 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 three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

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