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1h ago

FDA Clears Second Generic Mifepristone as HHS Review Proceeds

Health officials say they had to grant the copycat approval under federal generic‑drug rules requiring bioequivalence.

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FILE - In this photo illustration, a packet of Mifepristone is seen at Wyoming's last abortion clinic, Wellspring Center March 10, 2025 in Casper, Wyoming. (Photo illustration by Natalie Behring/Getty Images)
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FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Overview

  • The FDA informed Evita Solutions this week that its 200 mg mifepristone tablets are bioequivalent to Danco’s Mifeprex, making it the second approved generic.
  • HHS says the agency has very limited discretion on generics and must approve applications that match the reference drug, and generic applicants are not required to submit independent safety data.
  • The approval landed as HHS and the FDA conduct a safety review of mifepristone announced last month by Secretary Robert F. Kennedy Jr. and Commissioner Marty Makary.
  • Anti-abortion groups and Republicans, including Sen. Josh Hawley, SBA Pro-Life America and Students for Life, condemned the move, and Mike Pence called it a “complete betrayal.”
  • Experts and major medical societies continue to affirm the drug’s safety and have criticized a widely cited EPPC analysis as flawed, while state abortion restrictions limit how much a new generic changes access.