USA – FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports

The US Food and Drug Administration (FDA) on Wednesday said it plans to withdraw the approval of 249 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit annual reports for the generic drugs.

FDA says the manufacturers will have the opportunity to request a hearing to appeal the decision by filing a written request and providing the agency with a rationale for why the ANDA should not be withdrawn…