| GenBioPro | |
|---|---|
| Industry | Pharmaceutical |
| Headquarters | United States |
Area served | United States |
| Products | mifepristone |
| Website | https://genbiopro.com/ |
GenBioPro is a United States pharmaceutical company which makes and distributes a generic version of the medication abortion drug mifepristone.
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). Lauren Gardner, writing for Politico, reports that despite FDA's aim to approve generic drug applications in 10 months, the GenBioPro application (in 2009) was only approved after 10 years.
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.[needs update]
The FDA approved the original version of mifepristone in 2000 and gradually eased access over time. That included approving the first generic pill, from drugmaker GenBioPro, in 2019.
The agency typically aims to approve abbreviated new drug applications—those submitted for generics—within 10 months, but the process can take longer depending on how many questions or concerns reviewers have. There's also precedent for the FDA to take time on mifepristone decisions—GenBioPro, the first generic maker for the drug... applied for approval in 2009 and fielded a rejection in 2018 before getting approval the following year during the first Trump administration.