Overview

• Evita Solutions said the FDA cleared its mifepristone generic, making it the second approved generic alongside GenBioPro for use up to 70 days of gestation.
• The FDA stated it is legally obligated to approve generics that meet quality, safety, and efficacy standards, framing the move as a technical decision rather than a political one.
• Anti‑abortion groups and Republicans including Marjorie Dannenfelser, Josh Hawley, and Mike Pence condemned the approval, with Pence urging the removal of health adviser Robert F. Kennedy Jr.
• The American Medical Association reaffirmed that mifepristone is extremely safe and warned that restricting access would endanger public health.
• Evita indicated its product could reach the market in January, though distribution will be constrained by REMS requirements and by state laws or court orders.