Fifth Circuit Mifepristone Ruling May Temporarily Halt Pharmacy Dispensing, Generic Approval

 
• By Brenda Sandburg

Appeals court reverses district court’s stay of FDA’s approval of the medication abortion pill but pauses all agency actions taken since 2016, including changes to REMS and approval of GenBioPro’s generic mifepristone. DOJ and Danco are appealing to the Supreme Court on Friday.

FDA and pill
Fifth Circuit retains FDA's 2000 approval of mifepristone medicatoin abortion pill • Source: Shutterstock

More from US FDA

More from Agency Leadership