Overview

• The FDA approved Evita Solutions’ 200 mg mifepristone as therapeutically equivalent to Mifeprex, marking the second generic version of the medication.
• HHS stated the agency must approve compliant generics and confirmed a study of reported adverse effects as part of a broader review of mifepristone’s safety controls.
• Conservative lawmakers and anti-abortion groups denounced the decision, with figures such as Sen. Josh Hawley, Marjorie Dannenfelser, and Mike Pence calling for a reversal.
• Critics have cited an Ethics and Public Policy Center analysis claiming roughly 11% serious complications, a non–peer-reviewed finding disputed by researchers and decades of published studies.
• Evita says it expects to launch the product in January 2026, as medication abortion remains the predominant method in the U.S. and access continues to be shaped by state restrictions and ongoing lawsuits.