FDA Quietly Approves Generic Mifepristone Tablet for Abortion

Prior to the government shutdown, the FDA quietly approved an abbreviated new drug application for mifepristone tablets 200 mg as a bioequivalent and therapeutic equivalent generic medication to the reference product, Mifeprex 200 mg. The ANDA was received for review on October 1, 2021, according to a letter from the FDA.¹

Prior to the government shutdown, the FDA approved a generic version of mifeprisone without a public announcement. | Image Credit: Carl - stock.adobe.com

There are large sections of the country that ban abortion, and even though federally the FDA has approved mifepristone and said that it's safe and effective following the Dobbs decision, and even prior to the Dobbs decision, there are restrictions on providing abortion medication in different states and who can provide that in a state,” Nicole Cieri-Hutcherson, PharmD, BCPS, MSCP, FCCP, clinical associate professor at the University at Buffalo, said in an interview.²

In the 1980s, French researchers developed mifepristone with misoprostol for medication abortion care, and it was officially approved in France in 1988. In the United States, the FDA banned the importation of mifepristone in 1989. It wasn’t until September 2000 when mifepristone was approved by the FDA. The approval was for the drug to be used with misoprostol to end a pregnancy that is less than 70 days in duration, and it stops the supply of hormones, causing the uterus to be unable to support pregnancy. In April 2019, the FDA approves the first generic medication of mifepristone, which was indicated for the same as the reference product.^3-5

In 2022, the US Supreme Court ruled on Dobbs v Jackson Women’s Health Organization, which revoked the constitutional right to abortion established in the Roe v Wade decision. The right to access was returned to the states due to this ruling. Thirteen states enacted trigger laws designed to ban abortion when the federal protections were overturned. Since then, the conversation around abortion access has continued to make headlines.^6,7

“The most significant challenges that pharmacists face are related to the ever-evolving legislation involving abortion medication care,” Cieri-Hutcherson said.² “There are state laws that ban or restrict abortion and abortion medication, and they don't just apply to abortion procedures. It can apply to the abortion medication as well.”

In a study published by JAMA Network Open, national support for and personal interest in expanded access to medication abortion in the US has increased since the Dobbs decision. Investigators found that support for advanced provisions for abortion increased from 48.9% to 55.1%, and support for OTC increased from 49.4% to 55.2%. In another study published in Women’s Health Issues, investigators noted that abortion-providing clinics, which can also provide contraceptive care, sexually transmitted infection testing and treatment, and cervical cancer prevention and screening, face many barriers to providing preventative reproductive health with abortion care.^8,9

Because of the closure of these clinics, pharmacists have the opportunities to fill gaps in contraceptive care, but this role is limited by state authorization. However, there is also an opportunity to counsel patients on medication abortions as well as other reproductive health care topics.⁹

“As a highly trained health care professional, a pharmacist can not only dispense the medication but talk the patient through how the therapeutic indication works, how the medication works, interactions, [adverse] effects to expect, what to expect with bleeding, and those very rare other [adverse] effects that might occur that are part of the medication guide,” Cieri-Hutcherson said.²

READ MORE: Women's Health Resource Center

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REFERENCES

1. US Food and Drug Administration. ANDA approval for Mifepristone Tablets, 200 mg; ANDA 216616. US Food and Drug Administration; September 30, 2025. Accessed October 3, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf

2. Meara K, Cieri-Hutcherson N. Q&A: pharmacists help close gaps in abortion medication access. Drug Topics. June 30, 2025. Accessed October 3, 2025. https://www.drugtopics.com/view/q-a-pharmacists-help-close-gaps-in-abortion-medication-access

3. Reproductive Health Access Project. The history of mifepristone. April 18, 2023. Accessed October 3, 2025. https://www.reproductiveaccess.org/2023/04/history-of-mifepristone/

4. Mayo Clinic. Mifepristone (oral route). Accessed October 3, 2025. https://www.mayoclinic.org/drugs-supplements/mifepristone-oral-route/description/drg-20067123

5. FDA. Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. February 11, 2025. Accessed October 3, 2025. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation

6. Massaro L. Dispensing hope: how pharmacists are advocating for abortion access. Drug Topics. March 20, 2024. Accessed October 3, 2025. https://www.drugtopics.com/view/dispensing-hope-how-pharmacists-are-advocating-for-abortion-access

7. Massaro L. Supreme Court considers mifepristone limits in first case since Dobbs. Drug Topics. March 28, 2024. Accessed October 3, 2025. https://www.drugtopics.com/view/supreme-court-considers-mifepristone-limits-in-first-case-since-dobbs

8. Meara K. National support for medication abortion access increased since Dobbs decision. Drug Topics. January 16, 2025. Accessed October 3, 2025. https://www.drugtopics.com/view/national-support-for-medication-abortion-access-increased-since-dobbs-decision

9. Nowosielski B. Patients must seek pharmacists, other providers for reproductive health as abortion clinics close. Drug Topics. September 12, 2025. Accessed October 3, 2025. https://www.drugtopics.com/view/patients-must-seek-pharmacists-other-providers-for-reproductive-health-as-abortion-clinics-close