Evita Says FDA Approved Generic Mifepristone; Anti-Abortion Groups Denounce Move

The Big Picture

Evita Solutions LLC says the U.S. Food and Drug Administration approved its 200 mg generic mifepristone in September 2025 for use, with misoprostol, to terminate early pregnancy up to 70 days from the first day of the last menstrual period .

What’s New

The company describes the product as “coming soon” and emphasizes that access will continue under the FDA’s Risk Evaluation and Mitigation Strategy for mifepristone. Evita says prescribers must complete certification and that pharmacies seeking to dispense the drug must also be certified. The medication is prescription-only and not available over the counter. Telemedicine prescribing may be used where state law permits, according to the company.

What They’re Saying

Context

Mifepristone has been used in the United States since 2000 as part of a two-drug regimen, paired with misoprostol, to end early pregnancy. Evita characterizes the regimen as 97% effective and notes that federal safeguards, including warnings about rare but serious risks, underpin the REMS restrictions. Availability varies by state and depends on certified prescribers, certified pharmacies, and local regulations.

What’s Next

Evita has not announced a retail availability date. The company is directing providers and pharmacies to complete the certification steps so they can dispense once distribution begins. Policy groups have signaled further advocacy, including petitions and calls for additional FDA review.

The Bottom Line

Evita’s announcement signals another generic option within an established regimen while keeping existing federal safeguards and state limits in place. Supporters frame it as continuity of evidence-based access; opponents vow to keep pressing regulators and policymakers.

Follow Virginia Times for continuing coverage.