Overview

• The FDA on Tuesday approved Evita Solutions’ 200 mg mifepristone tablets as bioequivalent to Danco’s Mifeprex, adding a second generic option for use through 10 weeks of pregnancy.
• Health Secretary Robert F. Kennedy Jr.’s office said federal law gives the agency very limited discretion and requires approval when a generic proves identical to the brand-name drug.
• Kennedy and FDA Commissioner Marty Makary recently confirmed a review of real‑world safety data for mifepristone and the agency’s risk‑mitigation requirements.
• Conservatives including Sen. Josh Hawley, Susan B. Anthony Pro‑Life America, Students for Life, and Mike Pence denounced the decision, with Hawley saying he has lost confidence in FDA leadership.
• Medical groups maintain the regimen is safe and effective, state-level restrictions and lawsuits continue to shape access, and the additional generic is not expected by itself to significantly change availability.