Generic Abortion Pill Approved

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Generic Abortion Pill Approved

The Food and Drug Administration (FDA) has approved a new generic version of the abortion pill mifepristone, produced by the company Evita Solutions.


The FDA issued its approval on Tuesday, October 2, 2025, during a period of heightened debate over medication abortion and amid pressure from anti-abortion groups. 

Key details regarding the approval:
  • What was approved: The FDA found that Evita Solutions’s mifepristone tablets are “therapeutically equivalent” to the original brand-name version, Mifeprex, which was first approved in 2000. This makes Evita Solutions the second company authorized to sell a generic version of the drug, after GenBioPro received approval in 2019.
  • Generic drug process: Federal law requires the FDA to approve a generic drug if it is shown to be identical to the brand-name version. The Department of Health and Human Services (HHS) stated that the agency has “very limited discretion” in this process.
  • Medication abortion: Mifepristone is used in combination with another drug, misoprostol, for a medication abortion. This process accounts for about two-thirds of all abortions in the United States.
  • Context of the approval: The decision comes as the Trump administration’s Health and Human Services and FDA are conducting a review of mifepristone’s safety, following requests from Republican attorneys general. Abortion opponents, including some conservative lawmakers and anti-abortion groups, swiftly criticized the approval.
  • Company’s mission: Evita Solutions states on its website that it seeks to “normalize abortion care” and increase access to it. 

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