Deadline Set for Generic-Drug Makers to Withdraw Pending ANDAs or Pay Fee

Generic-drug makers have until Sept. 28 to either withdraw pending ANDAs or face a backlog fee, the FDA says. ANDA applicants should begin submitting written notification to the FDA by Sept. 15 if they wish to withdraw their applications, according to a Federal Register notice. Requests should be sent via the FDA’s electronic gateway if the ANDA was submitted through the gateway.
Washington Drug Letter