FDA Signs off on New Version of Abortion Pill Mifepristone

FRIDAY, Oct. 3, 2025 (HealthDay News) — A new low-cost version of the abortion pill mifepristone just received federal approval and it’s already stirring political controversy.

The U.S. Food and Drug Administration (FDA) recently granted approval to Evita Solutions for its generic version of mifepristone, a medication used to end early pregnancies up to 10 weeks. 

The original version of mifepristone has been available in the U.S. for 25 years and is commonly prescribed alongside another medication, misoprostol, to complete a medication abortion.

Evita “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care,” the company said.

While the approval process for generic drugs is usually routine, this decision quickly caused backlash from anti-abortion groups, The Associated Press reported.

Students for Life Action called the approval “a stain on the Trump presidency  and another sign that the deep state at the FDA must go.”

Meanwhile, Republican Sen. Josh Hawley of Missouri wrote in an X post that he had "lost confidence in the leadership at FDA."

The criticism comes as Trump administration and other health leaders, including U.S. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, face ongoing pressure from anti-abortion groups to revisit the safety of mifepristone. 

In a letter sent last month, the two officials said they plan to review the drug’s safety record despite decades of data showing it is safe and effective.

The drug was first approved in 2000 and later expanded for use through 10 weeks of pregnancy. 

The FDA approved the first generic version in 2019. Under the Biden administration, rules were updated to allow the pill to be prescribed via telehealth and shipped by mail, expanding access to women nationwide.

The latest approval adds another generic option to the market, but it's not expected to change access in states where abortion is still restricted or banned. 

Currently, medication abortion accounts for about two-thirds of all abortions in the U.S., The Associated Press said.

Major medical organizations such as the American Medical Association continue to support access to mifepristone, stating that restrictions are not based on scientific evidence.

More information

The Mayo Clinic has more on mifepristone.

SOURCE: The Associated Press, Oct. 2, 2025

What This Means For You

The approval adds another low-cost version of mifepristone to the market, but access remains limited in states with abortion bans.