Despite promising safety review, FDA approves another generic abortion pill
The FDA has just approved a new generic version of Mifeprex (mifepristone 200mg) abortion pill, as evidenced by a letter sent to Evita Solutions, LLC, on September 30.
According to Dun & Bradstreet, the principal for Evita Solutions — a pharmaceutical manufacturer — is Robert Patane, and the business is located in Glen Allen, Virginia. According to Susan B. Anthony Pro-Life America, Evita Solutions describes its mission as one to "normalize abortion" and make it "accessible to all."
Key Takeaways:
On Tuesday, the FDA quietly approved a new generic version of the abortion drug mifepristone.
The company behind the generic mifepristone is Evita Solutions LLC, which said its mission is to "normalize abortion" and make it "accessible to all."
The decision comes just days after HHS Secretary Robert F. Kennedy Jr said that the FDA will be reviewing the safety of mifepristone.
Kennedy had previously accused the Biden administration of having "twisted the data" on the safety of the abortion pill.
The Details:
On Tuesday, the FDA quietly approved a new generic version of the abortion pill Mifeprex, as stated in a letter sent to Evita Solutions, LLC. Evita Solutions had previously sent an abbreviated new drug application (ANDA) for mifepristone to the FDA on October 1, 2021.
In the letter, the FDA said the generic mifepristone tablets, 200 mg, are approved for use as of the date of the letter: September 30, 2025.
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.
"We have completed the review of this ANDA and have concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval under the FD&C Act," states the letter. "Accordingly the ANDA is approved, effective on the date of this letter. We have determined your Mifepristone Tablets, 200 mg to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mifeprex (mifepristone) tablets, 200 mg, of Danco Laboratories, LLC NDA - 020687."
The letter also states that the FDA will determine if a risk evaluation and mitigation strategy (REMS) "is necessary to ensure that the benefits of the drug outweigh the risks":
"The details of the REMS requirements were outlined in our REMS notification letter dated January 26, 2022.
The Mifepristone REMS Program is an approved single, shared system (SSS) REMS for mifepristone 200 mg tablets, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation; it includes Elements to Assure Safe Use (ETASU) and an implementation system.
Your final proposed REMS, received on April 16, 2025 is approved. Your product will be included in the Mifepristone REMS Program and will be posted on the FDA REMS website: http://www.fda.gov/rems."
The REMS must be "fully operational" before the drug is made available for purchase.
The news of the FDA's approval of a generic version of Mifeprex comes just days after HHS Secretary Robert F. Kennedy Jr. said the FDA is reviewing the safety of Mifeprex itself. In June, Kennedy asked FDA Commissioner Martin Makary to "review the latest data" on the drug. He has accused the Biden administration of having "twisted the data" on the safety of the abortion pill.
In a letter dated September 19, Kennedy and Makary wrote, "HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug [mifepristone]."
Kennedy and Makary did not say when the review would be completed, but said, "We will keep you informed as the FDA's review of mifepristone progresses."
What We're Hearing:
Reaction to this decision from pro-life politicians and others has been swift.
Senator Josh Hawley wrote on X, "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."
In a follow-up tweet, he wrote, "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."
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
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!
Josh Hawley
@HawleyMO
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.
Former VP Mike Pence also took to X to share his thoughts, writing, "The Trump Administration’s approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump.... President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new Secretary of HHS who will protect the sanctity of life. The fight for life continues."
The Trump Administration’s approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump.
Earlier this year, I opposed RFK’s nomination because he was unfit for the role and particularly over the concern that he would
Philip Melanchthon Wegmann
@PhilipWegmann
Trump’s FDA just approved the generic version of the abortion drug mifepristone.
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Abortion Pill·By Nancy Flanders
