In October 2025, federal officials approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration.
Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill, which is approved to end pregnancies through 10 weeks.
The FDA approved the original version of mifepristone in 2000 and gradually eased access over time. That included approving the first generic pill, from drugmaker GenBioPro, in 2019.
In 2021, the FDA under Democratic President Joe Biden permitted online prescribing and mail-order delivery of the drug, greatly expanding access. Abortion opponents have been fighting the change ever since.
Approval of generic drugs is typically a rote process at the FDA, with multiple copycat versions usually approved after the patent on the original drug expires. In most cases, generic drugmakers only need to show that their drug matches the ingredients and formula used in the original medication.
“This is exactly how our system is supposed to work, and it has worked this way for decades,” said Mini Timmaraju of Reproductive Freedom for All. “Career scientists and civil servants at the FDA did their jobs.”
The FDA typically approves such applications within 10 months. But filing documents posted to the FDA’s website show that Evita Solutions filed its application to market mifepristone four years ago.
On its website, Evita states that it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.”
The company said in an email that the drug is expected to launch in January 2026. The combination of mifepristone and misoprostol accounts for roughly two-thirds of all U.S. abortions.
SOURCE: National Public Radio (NPR), The Associated Press, 2 October 2025.
VISUAL: The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, D.C., on 22 April 2025, by Jose Luis Magana/AP.