Alaco, Inc., et al.; Proposal To Withdraw Approval of Seven New Animal Drug Applications; Opportunity for a Hearing

摘要

The Food and Drug Administration's (FDA or Agency) Center for Veterinary Medicine (CVM) is proposing to withdraw approval of seven new animal drug applications (NADAs) and is announcing an opportunity for the NADA holders to request a hearing on this proposal. The basis for the proposal is that the NADA holders have repeatedly failed to file required annual reports for those NADAs.