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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

The US Food and Drug Administration’s approval of mifepristone remains in effect but the US Court of Appeals for the Fifth Circuit let stand a district court’s stay of all agency actions taken since it modified the Risk Evaluation and Mitigation Strategy for the medication abortion drug in 2016.

That means that unless the decision is reversed patients will no longer be able to obtain mifepristone by mail or in pharmacies and may also mean that the approval of GenBioPro’s sole generic version of mifepristone is stayed

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