FDA Approves Second Generic Mifepristone

On Sept. 30 the FDA approved a generic mifepristone from Evita Solutions, making it the second U.S. generic on the market alongside GenBioPro and formally deeming Evita’s product therapeutically equivalent to Danco’s Mifeprex. Evita said it will market the drug under the same labeling as the brand and said its mission is to “normalize abortion” to expand access; medication abortion using mifepristone plus misoprostol accounts for a large share of U.S. abortions. The routine regulatory finding drew sharp criticism from anti‑abortion politicians and groups, including Sen. Josh Hawley, Susan B. Anthony Pro‑Life America and Students for Life, who said it undercuts a promised top‑to‑bottom safety review announced by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. HHS and FDA officials said they would re‑examine real‑world evidence but noted agencies have limited discretion to deny generics that demonstrate equivalence. Critics highlighted an unpublished Ethics and Public Policy Center analysis alleging high complication rates, but experts have identified flaws in that paper and regulators point to mifepristone’s long safety record since its 2000 approval.