The Food and Drug Administration approved a second generic version of the abortion medication mifepristone on September 30, just hours before the federal government shutdown. 

The FDA’s approval letter to Evita Solutions confirmed that the company’s mifepristone tablets, 200 mg, are “bioequivalent and therapeutically equivalent” to the brand-name Mifeprex manufactured by Danco Laboratories. Evita Solutions originally filed its abbreviated new drug application on October 1, 2021, making the approval process nearly four years in duration.

This marks the second generic version of mifepristone available in the United States, following GenBioPro’s approval in 2019. With three companies now authorized to manufacture mifepristone for abortion purposes, the approval could potentially increase competition and reduce costs for patients seeking medication abortions.

The generic drug will be subject to the existing Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, which requires certified providers and pharmacies to meet specific conditions for prescribing and dispensing the medication. Evita Solutions’ final proposed REMS was approved in April 2025, and the product must be fully operational under these safety protocols before entering interstate commerce.

Mifepristone, used in combination with misoprostol, accounts for approximately two-thirds of all abortions performed in the United States. The medication is approved for terminating pregnancies through 10 weeks of gestation (70 days from the last menstrual period).

Despite the generic approval, Kennedy has indicated that the broader mifepristone safety review will continue.