The FDA has approved a second generic version of mifepristone from Evita Solutions. The approval was issued on September 30, 2025.
Evita Solutions applied to manufacture the generic mifepristone on October 1, 2021. The FDA typically aims to approve generic drug applications within 10 months, though the process can take longer depending on reviewer questions and concerns.
Mifepristone was first approved in combination with misoprostol in 2000 under the brand name Mifeprex, manufactured by Danco Laboratories. The drug is used to terminate pregnancy at up to 10 weeks of gestation. Mifepristone blocks progesterone, the hormone that helps maintain the uterine lining during pregnancy, and misoprostol is then taken to complete the abortion process. Medication abortions account for approximately two-thirds of abortion procedures across the United States.
GenBioPro manufactures the first generic mifepristone, which received FDA approval in 2019. GenBioPro initially applied for approval in 2009 and received a rejection in 2018 before final approval.
The FDA has stated that after decades of use by millions of women in the United States and around the world, mifepristone has proven extremely safe, with serious adverse events being exceedingly rare.
