Federal regulators have approved a second generic version of the abortion pill mifepristone.

Drugmaker Evita Solutions announced on its website that the Food and Drug Administration had cleared its low-cost version of the pill, which is approved to end pregnancies up to 10 weeks.

Why it matters

Mifepristone was first approved in 2000 and has been gradually made more accessible. The FDA authorized the first generic version, manufactured by GenBioPro, in 2019. Two years later, under Democratic President Joe Biden, the agency permitted telehealth prescribing and mail-order delivery of the drug, a policy shift that dramatically expanded access. Abortion opponents have been challenging that decision in court ever since.

What to know

In a letter to Republican attorneys general last month, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of mifepristone, which was approved 25 years ago and has repeatedly been deemed safe and effective by FDA scientists.

Generic approvals are usually considered routine. After the patent on the original drug expires, multiple drugmakers often enter the market with cheaper versions. To receive approval, companies must demonstrate that their product is chemically identical to the original. In most cases, such reviews are completed within 10 months.

But Evita’s application took far longer. According to FDA filings, the company submitted its request four years ago. The FDA did not explain the delay.

Evita did not immediately respond to requests for comment. On its website, the privately held company says it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.”

Major medical groups, including the American Medical Association, oppose restrictions on the pill, saying they are not supported by scientific evidence.

What happens next

Approval of Evita’s pill is not expected to significantly alter access to mifepristone.

Still, access to the regimen remains sharply limited in many states. Abortion bans — including bans on medication abortion — have been enacted across large parts of the country. Other states have passed restrictions specific to mifepristone. Those measures remain tied up in ongoing legal challenges.

In August, Costco Wholesale cited low demand and announced it would not sell mifepristone in its U.S. pharmacy stores. (Source: Newsweek)

Story Date: October 3, 2025