Overview

• The FDA quietly issued an approval letter this week to Evita Solutions for a therapeutically equivalent version of mifepristone, bringing the number of U.S. manufacturers to three.
• A White House spokesperson said the decision is not an endorsement of the product and emphasized that the agency must approve generics that match the brand-name drug.
• HHS confirmed the department is conducting a study of reported adverse effects to reassess risk controls for mifepristone.
• Conservative leaders and groups, including Mike Pence, Sen. Josh Hawley and SBA Pro-Life America, condemned the approval and urged the administration to reverse it.
• Evita’s application was filed years earlier and the company says it expects to begin marketing in January 2026, with experts noting the added generic is unlikely to change access in states with existing restrictions.