FDA Approves Generic Mifepristone Tablets for Abortion

The Food and Drug Administration (FDA) approved a generic version (Evita Solutions) of mifepristone (Danco Laboratories) available in 200-mg oral tablets on Tuesday, quietly widening the options for aborting pregnancy before the government shut down at midnight that evening.

This approval brings the total number of American companies who produce mifepristone for abortion to 3, expanding supply at a time where access may be restricted in certain areas within the US. Mifepristone carries out about two-thirds of medical terminations of pregnancy.¹

Mifepristone, which was initially approved by the FDA in 2000 and had its first generic version (GenBioPro) approved in 2019¹, is indicated with misoprostol for the medical termination of a pregnancy that is less than 70 days of gestation. The regimen requires patients 17 years or older to take a single 200-mg oral dose of mifepristone tablet, then 4 oral doses of misoprostol (200 mcg) which are administered 24 to 48 hours after the former. It stops the supply of hormones that maintain the interior of the uterus; without these hormones, the uterus cannot continue to support the pregnancy and expels the contents within the organ.²

Mifepristone can also be used to control high blood sugar caused by high cortisol levels in the blood in patients with Cushing syndrome who also have type 2 diabetes and have either failed surgery or cannot have it.²

Because this approval is for a generic version of mifepristone, it did not have to undergo the same rigorous process as other applications seeking first-time drug approvals. Typically, such application approvals occur within 10 months; however, filing documents show that this generic had its application filed 4 years ago. Additionally, the FDA stated that the same standards and regulations would apply to this new generic version as followed by the other 2 manufacturers of mifepristone. According to the manufacturer, the second generic is expected to launch in January 2026.^1,4

“The FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services (HHS) must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” Andrew Nixon, a spokesperson for HHS said in a statement. “Generic applicants are not required to submit independent evidence proving safety and effectiveness. HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”⁴

The FDA emphasized that the generic version will be subject to the existing Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, which is a single, shared system that includes Elements to Assure Safe Use (ETASU) and an implementation system. Further, the generic product must comply with all REMS requirements prior to entering interstate commerce. The manufacturer’s final proposed REMS was approved in April 2025, and the product will be included in the Mifepristone REMS Program.³

REFERENCES

1. Belluck P. F.D.A. Approves Generic Abortion Pill as Opponents Push Trump for New Restrictions. The New York Times. Updated October 3, 2025. Accessed October 3, 2025. https://www.nytimes.com/2025/10/02/health/abortion-pill-generic-fda.html?unlocked_article_code=1.qk8.rgmp.hEkKQ9WMaZ8T&smid=url-share

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

3. US Food & Drug Administration. ANDA Approval. September 30, 2025. Accessed October 3, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf

4. Bendix A, Kapur S. FDA quietly approved a generic abortion pill ahead of shutdown. NBC News. October 2, 2025. Accessed October 3, 2025. https://www.nbcnews.com/health/womens-health/fda-approves-generic-abortion-pill-mifepristone-rcna235265