The US Food and Drug Administration (FDA) has approved Evita Solutions’ generic form of mifepristone, one of the two medications used in most US abortions, much to the fury of right-wing groups.
The approval was announced via a letter to Evita, with no public statement made by the agency nor the company. The absence of a press release in this case suggests an intention not to rouse the political spectrum.
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Mifepristone tablets were first approved in 2000 under the brand name Mifeprex, manufactured by Danco Laboratories. In the letter approving Evita’s abbreviated new drug application (ANDA), the FDA said the company’s 200mg mifepristone tablets are “bioequivalent and therapeutically equivalent” to Danco’s Mifeprex. Evita’s generic is available only under the FDA-approved Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program.
With the approval, Evita joins GenBioPro as the two generic manufacturers of mifepristone indicated for the medical termination of intrauterine pregnancy through 70 days of gestation.
As per its website, Evita says it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live”.
In an emailed statement to Pharmaceutical Technology, Evita said it was “pleased to announce the approval.”
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By GlobalData“Evita Solutions is now the third manufacturer (the second generic manufacturer) with FDA approval. Availability of our product will expand patients’ options for medication abortion with an affordable product backed by decades of safe use. The new product is expected to be available in January 2026,” the company added.
Mifepristone blocks progesterone, the hormone that helps a woman’s body maintain the lining of the uterus during pregnancy. Synthetic prostaglandin misoprostol is then administered to expel the pregnancy from the body. Medication abortion is used in nearly two-thirds of abortions, according to the Guttmacher Institute, a research organisation focusing on sexual and reproductive health.
The quiet FDA approval comes at a time when future access to abortion drugs in the US is under considerable political tampering. Health Secretary Robert F Kennedy (RFK) Jr said last month that the FDA would launch a review of abortion pills amid pressure from conservative and anti-abortion groups.
In a letter to Republican-led states, FDA Commissioner Marty Makary and RFK Jr wrote that the agency would conduct “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug”.
They added that the FDA’s past decisions to suspend certain restrictions on mifepristone access had not been given “adequate consideration” at the time.
If the FDA were to implement mifepristone restrictions, it would further reduce abortion access in a post-Roe versus Wade America. In 2022, the Supreme Court ended the federal constitutional right to abortion and returned the authority to regulate abortion to individual states. At least 16 states have since pulled back nearly all abortion services. However, the Supreme Court preserved mail-order access to the abortion pill last year.
Politicised response to scientific evidence
The approval of a second mifepristone generic was met with a divisive reaction.
“Secretary Kennedy and FDA Commissioner Makary assured Congress and the American people they would conduct a thorough review given credible evidence of the harm inflicted by these drugs. The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug,” said Marjorie Dannenfelser, president of anti-abortion group SBA Pro-Life America.
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution,” Josh Hawley, a Republican senator from Missouri and abortion opponent, wrote on X.
A wealth of scientific evidence across dozens of countries over the past few decades do not support claims that abortion pills inflict harm, with serious adverse events being rare.
Supporters of abortion rights, meanwhile, welcomed the FDA’s latest approval.
Reproductive Freedom for All president and CEO Mini Timmaraju said: “This is exactly how our system is supposed to work, and it has worked this way for decades. Career scientists and civil servants at the FDA did their jobs—evaluating the evidence and approving a safe, effective medication.
“The only reason this routine approval is making headlines is because anti-abortion politicians have turned healthcare into a political battlefield. We miss the days when this didn’t require a comment.”
National Abortion Federation CEO Brittany Fonteno said in a statement that the approval of a second generic drug for mifepristone “underscores what research has shown for decades: medication abortion is safe, effective, and essential health care, used by millions with proven efficacy”.
Editor’s note: This article was updated on 3 October to include comment from Evita.
