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FDA Approves New Generic Abortion Pill as Lawsuit Moves to Missouri

The FDA approved a new generic mifepristone pill to expand access amid ongoing political and legal challenges, with medication abortions now comprising nearly two-thirds of U.S. abortions.

  • On Tuesday, the U.S. Food and Drug Administration quietly approved a new generic mifepristone from Evita Solutions, approved for use through 10 weeks.
  • Evita filed its application four years earlier, and federal law requires the FDA to approve generics shown bioequivalent under the Hatch‑Waxman Act.
  • Conservative critics including Sen. Josh Hawley and Students for Life Action blasted the approval Thursday, while Reproductive Freedom for All's Mini Timmaraju said, `This is exactly how our system is supposed to work, and it has worked this way for decades.`
  • Medication abortions account for nearly two-thirds of U.S. abortions, but access remains restricted in U.S. states with laws banning or limiting medication abortion.
  • Last month, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, MD, MPH pledged a full safety review after 22 Republican attorneys general requested it; the EPPC study claimed almost 11% serious complications but faced criticism.
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Opponents of abortion have fought against change.

·Los Angeles, United States
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Center

Pro-life group calls FDA’s approval of generic abortion pill ‘unconscionable’

(The Center Square) – A pro-life organization called the FDA’s approval of the generic version of the abortion drug mifepristone “unconscionable,” stating that abortion is the leading cause of death in the nation, that the abortion pill undermines states’ rights,…

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KMJ-AF1 broke the news in on Wednesday, October 1, 2025.
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