GenBioPro is a United States pharmaceutical company which makes and distributes a generic version of the medication abortion drug mifepristone.
History
In 2019 GenBioPro obtained Food and Drug Administration (FDA) authorization to sell a generic version of mifepristone (before that, Danco Laboratories was the only company that distributed it in the United States).[1][2] Despite the FDA saying that it tries to approve generic drug applications in 10 months, this application was approved after 10 years (the company applied in 2009).[3]
In 2023, GenBioPro sued the FDA to obtain a legal judgement confirming that mifepristone could continue to be sold, in spite of anti-abortion laws passed in some states.[4][5]
See also
- Birth control movement in the United States
- Exelgyn
- Medical abortion
References
- The first generic abortion pill just hit the US market. Here's what that means. Vox, 20 August 2019, retrieved 14 July 2020^
- Matthew Perrone. FDA approves another generic abortion pill, prompting conservative backlash Associated Press, 2025-10-02^
- Lauren Gardner. FDA approved new generic abortion pill before shutdown Politico, 2025-10-02^
- "Generic abortion pill manufacturer sues FDA in effort to preserve access" Sarah McCammon April 19, 2023 NPR https://www.npr.org/2023/04/19/1170806176/abortion-pill-mifepristone-supreme-court-fda-generic-genbiopro^
- Pam Belluck. Abortion Pill Maker Sues F.D.A. to Protect Drug if a Court Orders It Off the Market The New York Times, 2023-04-19, retrieved 2025-03-06^