FDA Approves Evita Solutions' Generic Mifepristone for Abortion
Evita Solutions' generic version of mifepristone, an abortion pill, is set to launch in January 2026. The FDA approved the drug, which will be available up to 10 weeks of pregnancy. However, the decision has sparked controversy, with anti-abortion groups and politicians criticising the move.
The FDA's approval of Evita Solutions' mifepristone comes after Accord Healthcare received approval for a similar generic version in April 2025. Mifepristone, often used in combination with misoprostol, accounts for around two-thirds of U.S. abortions. Major medical societies, including the American Medical Association, do not support restrictions on the pill.
The FDA's decision has been criticised by anti-abortion groups such as Students for Life Action and Sen. Josh Hawley. They argue that the FDA should have more discretion in approving generic drugs. However, the FDA maintains that it does not endorse any product and has limited discretion in the approval process. Critics also point to the FDA's history of delaying decisions on vaccines and narrowing approval terms under the current administration.
Despite the controversy, Evita Solutions' mifepristone is expected to launch in January 2026. Access to the drug remains restricted in many U.S. states due to abortion laws and ongoing legal challenges. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have pledged to review mifepristone's safety under pressure from abortion opponents.
