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FDA Approves Second Generic Mifepristone as Evita Solutions Wins Bioequivalence Finding

Federal law required action once the copy met bioequivalence criteria.

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.