FDA approves second generic mifepristone from Evita Solutions

Federal regulators approved a second generic version of the abortion drug mifepristone on Thursday, clearing a low-cost formulation made by telehealth company Evita Solutions that is approved for use through 10 weeks of pregnancy, company materials and federal documents show. The authorization is likely to increase the number of manufacturers supplying the drug in parts of the country where medication abortion remains legal, though access will continue to be shaped by state laws and ongoing litigation.

Mifepristone, typically used in combination with misoprostol, was first approved under the brand name Mifeprex in 2000 and has become the dominant method of abortion in the United States. The FDA approved the first generic version in 2019. Officials say generic approvals generally require companies to demonstrate that their product is essentially identical to the brand drug, a standard that often makes such approvals routine. Filings on the FDA website indicate Evita Solutions submitted its application roughly four years ago.

Evita states on its website that it believes "all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care."...