What to know about the new FDA-approved generic abortion pill

Another version of the abortion pill will soon be available, following approval by the Food and Drug Administration, the nation’s drug regulator.

This approval means another generic form of mifepristone can be produced and will be available at pharmacies and through the mail. The pill, which requires a prescription, can be taken at home under medical supervision or at a clinic and is typically taken with a second pill, misoprostol.

The FDA approved the medication without a public announcement and did so before the government shutdown. Anti-abortion groups have expressed outrage over the move.

Here are questions and answers about what it means.

What did the FDA approve?

In a letter dated Sept. 30, the agency approved an additional generic version of the abortion drug mifepristone, this one by the company Evita Solutions. The company says on its website "we seek to normalize abortion care, and we commit to making care accessible to all."

Isn’t there already an abortion pill?

Yes, the original version of the drug, Mifeprex, was approved in 2000, and the first generic pill was approved in 2019, according to an FDA product guide.

That generic version brought down the price of the drug, said Ushma Upadhyay, a public health scientist at the University of California San Francisco.

"With this new one, it’s possible that the price could come down further," she told Newsday, "which would really increase access, especially for people [living in states] with abortion bans who have these tremendous barriers to abortion care."

When will the new pill hit the market?

Upadhyay said the company has not released information about timing, but its website says: "A new generic mifepristone product is coming soon."

How does it work?

Mifepristone "stops the pregnancy from growing." That’s followed up by the drug misoprostol, which "causes cramping and bleeding" and "is very similar to an early miscarriage," according to a guide published by Planned Parenthood Federation of America Inc., which provided 402,200 abortions according to its 2023-24 annual report. Nationwide, there were over 1 million abortions from all providers in 2024, according to the Guttmacher Institute.

What share of abortions are done via pill?

Those accounted for about 63% of all abortions in the United States in 2023, which is a 53% increase from 2020, according to the institute. Beginning in 2021, "the FDA lifted medically unnecessary restrictions that had required in-person provision of mifepristone."

What is the cost?

The median price nationally was about $563 in 2023 — about $600 for an in-person appointment and $150 at a virtual clinic, according to a paper Upadhyay co-authored last year in the journal Perspectives on Sexual and Reproductive Health. But the price varies by location and insurance.

How effective are abortions via pills?

Between 95% and 97%, according to a patient education guide from the University of California San Francisco, but sometimes "patients need an additional aspiration procedure due to ongoing pregnancy, prolonged or excessive bleeding, or preference."

How far along in the pregnancy can the mother be and still use the pills to terminate the pregnancy?

Up to 10 or 11 weeks, the guide says. The Evita webpage says it can be used up to 70 days "from the first day of the last menstrual period."

Is there controversy surrounding the approval?

Yes, some anti-abortion groups who are allied with President Donald Trump and his administration are criticizing the approval, according to The Associated Press. The anti-abortion group Students for Life Action wrote in a statement the approval is "a stain on the Trump presidency and another sign that the deep state at the FDA must go."

Health and Human Services Secretary Robert F. Kennedy Jr. said: "FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug."

By Matthew Chayes

matthew.chayes@newsday.comchayesmatthew

Matthew Chayes, a Newsday reporter since 2007, covers New York City.