FDA approves generic mifepristone tablet for abortion

FDA approves generic mifepristone tablet for abortion | Image credit: Contemporary OBGYN

On October 2, 2025, FDA approved the first generic version of mifepristone tablets, 200 mg, submitted by Evita Solutions, LLC. The approval, issued under an Abbreviated New Drug Application (ANDA) in 2021, confirms the product is bioequivalent and therapeutically equivalent to Mifeprex (mifepristone) 200 mg, marketed by Danco Laboratories.

Mifepristone, in combination with misoprostol, is indicated for the medical termination of intrauterine pregnancy through 70 days of gestation. The generic version will be subject to the existing Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, a single, shared system that includes Elements to Assure Safe Use (ETASU) and an implementation system.

FDA emphasized that the generic product must comply with all REMS requirements prior to entering interstate commerce. Evita Solutions’ final proposed REMS was approved in April 2025, and the product will now be included in the Mifepristone REMS Program.

The approval marks a significant regulatory milestone by expanding access to a generic version of mifepristone while maintaining strict safety protocols.

This is a developing story and will continue to be updated.

Reference:

FDA. ANDA Approval. Evita Solutions. Letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf