GenBioPro Amicus Brief in Alliance for Hippocratic Medicine v. FDA

This brief was filed on behalf of GenBioPro, which holds a U.S. Food and Drug Administration (“FDA”)-approved Abbreviated New Drug Application (“ANDA”) to market generic mifepristone. The brief emphasizes that the scientific data supporting the safety and effectiveness of mifepristone was even more robust in 2019 than in 2000 and that there is no rational basis to treat GenBioPro’s ANDA differently from Danco’s NDA in this litigation.

This brief was one of many filed in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.