
FDA Approves Second Generic Mifepristone Pill for Abortion
The FDA has approved a second generic version of oral mifepristone, used to terminate pregnancy, after determining it is identical to the branded drug.
The FDA Thursday
Mifepristone is used to terminate pregnancies through 10 weeks’ gestation; the pill is taken and then followed by misoprostol 24 to 48 hours later.2 The FDA’s website explains that
The originator drug was approved in 2000, and a first generic version of mifepristone was approved in April 2019. The
HHS spokesman Andrew Nixon said in a statement that “the FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.”3
Anti-abortion lawmakers and activists did not accept that explanation for the approval.
To straddle the demands of Trump’s base and the parameters of the agency’s powers, Kennedy and FDA Commissioner Marty Makary, MD, had vowed to
Meanwhile, organizations in favor of abortion access celebrated the generic approval, noting that mifepristone has been used for 25 years to safely and effectively manage abortions and miscarriages. “This is exactly how our system is supposed to work, and it has worked this way for decades,” Mini Timmaraju, president and CEO of Reproductive Freedom for All,
Although the entry of a second generic onto the market could induce lower prices, access to mifepristone is not just a matter of cost.
References
- ANDA 216616: ANDA approval. FDA. October 2, 2025. Accessed October 3, 2025.
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf - Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. FDA. 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 - Belluck P. F.D.A. approves generic abortion pill as opponents push trump for new restrictions. New York Times. October 2, 2025. Accessed October 3, 2025.
https://www.nytimes.com/2025/10/02/health/abortion-pill-generic-fda.html - Inserro A. Supreme Court overturns Roe v Wade, turning issue back to states. AJMC®. June 24, 2022. Accessed October 3, 2025.
https://www.ajmc.com/view/supreme-court-overturns-roe-v-wade-turning-issue-back-to-states - Grossi G. Democratic doctors caucus reaffirms EMTALA amid Trump's CMS policy reversal on abortion care. AJMC. June 18, 2025. Accessed October 3, 2025.
https://www.ajmc.com/view/democratic-doctors-caucus-reaffirm-emtala-amid-trump-era-policy-reversal - @SecKennedy. X. October 2, 2025. Accessed October 3, 2025.
https://x.com/SecKennedy/status/1973866621245567344 - Reproductive Freedom for All responds to FDA approval of new generic mifepristone. News release. Reproductive Freedom for All. October 2, 2025. Accessed October 3, 2025.
https://reproductivefreedomforall.org/news/reproductive-freedom-for-all-responds-to-fda-approval-of-new-generic-mifepristone/ - Diaz J, Selyukh A. CVS and Walgreens to start dispensing abortion pill in states where it’s legal. NPR. March 1, 2024. Accessed October 3, 2025.
https://www.npr.org/2024/03/01/1235265078/abortion-pill-cvs-walgreens-mifepristone - Sobel L, Gomez I, Salganicoff A. The intersection of state and federal policies on access to medication abortion via telehealth after Dobbs. KFF. July 24, 2025. Accessed October 3, 2025.
https://www.kff.org/womens-health-policy/the-intersection-of-state-and-federal-policies-on-access-to-medication-abortion-via-telehealth-after-dobbs/
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