Overview
- The FDA’s Tuesday letter to Evita Solutions deems its 200 mg tablets therapeutically equivalent to Danco’s Mifeprex.
- HHS said the agency has very limited discretion on generics and must approve applications that demonstrate identity to the reference drug.
- Evita filed its application in 2021, and the decision comes as HHS and the FDA conduct a broader review of mifepristone safety.
- Conservative groups and Republicans including Sen. Josh Hawley denounced the approval, while abortion-rights and medical organizations cited extensive evidence that serious adverse events are rare.
- This second generic follows GenBioPro’s 2019 clearance and is unlikely by itself to change access where state bans and other restrictions limit use.