The Federal and Drug Administration (FDA) has approved a generic form of mifepristone.
On Tuesday, the federal agency sent a letter to Evita Solutions to inform the company its drug application met the necessary requirements for approval.
The drug now becomes the second generic version to hit the market.
“The first, from pharmaceutical company GenBioPro, was approved in 2019,” NBC News noted.
“This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child,” Sen. Josh Hawley (R-MO) commented.
“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. I have lost confidence in the leadership at FDA,” he added.
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. I have lost confidence in the leadership at FDA
— Josh Hawley (@HawleyMO) October 2, 2025
NBC News has more:
Mifepristone is typically used in combination with another pill, misoprostol, to induce abortions. Medication abortions account for nearly two-thirds of abortions in the U.S.
The FDA wrote in a letter to Evita Solutions on Tuesday, the day before the government shutdown began, that its mifepristone tablets were “therapeutically equivalent” to the brand-name version, Mifeprex, which has been available in the U.S. since 2000.
On its website, Evita Solutions describes its mission as assisting “the medical community in recognizing the utility and freedom that medical abortion provides patients.”
“We seek to normalize abortion care, and we commit to making care accessible to all,” it adds.
Pro-life groups criticized the FDA for the approval:
The FDA is supposed to be doing a safety and efficacy review of the abortion drug mifepristone.
Instead, they have approved a new generic version of the drug, allowing more women to conduct DIY abortions and thus putting lives at risk.https://t.co/QkSrg3rM6o
— Concerned Women for America LAC (@CWforA) October 2, 2025
The #FDA wasn't created to make it easier to maim, disfigure or end human life. It wasn't created to make it more profitable for #bigpharma, or less expensive for our government to kill human beings. We are stunned by this decision & call for its reversal https://t.co/zKzcyCdXSo
— Family Policy Alliance (@family_policy) October 2, 2025
UNACCEPTABLE: The FDA just approved another generic of the abortion pill mifepristone. This drug starves babies and harms mothers! The FDA just said it would do a new serious safety study—so why approve a another generic now? @RobertKennedyJr must reverse this decision! https://t.co/DYtSAEFvMg
— Lila Rose (@LilaGraceRose) October 2, 2025
The Hill noted:
Last week, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced the agency would consider modifying the Risk Evaluation and Mitigation Strategy requirements, citing “recent studies raising concerns about the safety of mifepristone as currently administered.”
This action drew outcry from anti-abortion conservative voices.
Marjorie Dannenfelser, president of the anti-abortion group Susan B. Anthony Pro-Life America, called the decision “unconscionable.”
ADVERTISEMENT“These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation,” said Dannenfelser, reiterating calls for the Trump administration to reverse the Biden administration’s changes allowing for abortion pills to be sent through the mail.
