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FDA Approves Second Generic Mifepristone as Safety Review Proceeds

HHS says generic decisions follow bioequivalence requirements with limited agency discretion.

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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)
Demonstrators protest against abortion pill sales outside a CVS pharmacy on the same day the justices of the U.S. Supreme Court hears oral arguments in the case of the U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Torrance, California.
via AP Images)President Donald Trump makes an announcement about autism with National Institutes of Health Director Jay Bhattacharya, Food and Drug Administration Commissioner Marty Makary, Secretary of Health and Human Services Robert Kennedy Jr., and Medicare Services Administration Mehmet Oz in the Roosevelt Room of the White House, in Washington on Sept. 22, 2025. Francis Chung/POLITICO

Overview

  • Evita Solutions received FDA clearance Tuesday for 200 mg mifepristone tablets deemed therapeutically equivalent to the brand Mifeprex.
  • Conservative leaders condemned the move, with Sen. Josh Hawley saying he has lost confidence in FDA leadership and groups like SBA Pro-Life America calling the decision reckless.
  • Students for Life labeled the approval a stain on the Trump presidency, and Mike Pence urged President Trump to reverse the decision and remove HHS Secretary Robert F. Kennedy Jr.
  • HHS officials said law requires approval of generics that match the brand drug and noted that applicants are not required to submit new safety and efficacy data, as a broader mifepristone safety review continues.
  • Mifepristone, typically used with misoprostol, accounts for roughly two-thirds of U.S. abortions; Evita’s application was filed years earlier, and access remains shaped by state restrictions and ongoing litigation.