FDA-2025-P-5436

Requests that the FDA revoke its actions to approve the Abbreviate New Drug Application 216616, a generic version of Mifepristone, and modify the associated regimen (including the REMS) until the agency conducts the required consultation with the United States Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (collectively, “the Services”) as compelled by the ESA