WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing.
The notice was published in the Federal Register on Dec. 29 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file r...