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Mifeprex (mifepristone) is used, together with another medication called misoprostol, to end an early pregnancy. FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application for Mifeprex based on data and information submitted by the drug manufacturer. After reviewing the supplemental application, the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling. In 2019, FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg.

Misoprotol is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period).

FDA previously approved a REMS for Mifeprex. In 2019, at the same time FDA approved the generic version of Mifeprex, the agency approved a single, shared system REMS for mifepristone products for the medical termination of intrauterine pregnancy through 70 days gestation (the Mifepristone REMS Program). Under the 2019 REMS