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9m ago

FDA Approves New Generic Mifepristone as Lawsuit Moves to Missouri

Officials say federal law leaves little discretion on qualifying generics during the ongoing safety review.

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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

  • The FDA cleared Evita Solutions’ generic mifepristone for use through 10 weeks, acting on an application filed in 2021, according to agency correspondence and the company.
  • An HHS spokesperson said the agency must approve a generic shown to be identical to the brand‑name drug, noting FDA does not endorse products and directs prescribers to follow labeling.
  • Sen. Josh Hawley and anti‑abortion groups denounced the approval as unsafe and premature during the review, while a Planned Parenthood spokesperson welcomed another option supported by extensive evidence.
  • Two days earlier, Judge Matthew Kacsmaryk transferred red‑state challenges to the FDA’s mifepristone rules to the Eastern District of Missouri instead of dismissing the case, keeping the suit alive for potential merits consideration.
  • Access to the pill remains constrained by state abortion, telehealth, and mail restrictions, and FDA and major medical organizations have repeatedly found the mifepristone–misoprostol regimen safe and effective.