FDA Approves Generic Mifepristone – STAT News
- * Mifepristone's 25th anniversary: The article discusses the 25th anniversary of the FDA's approval of mifepristone, an abortion pill, in the U.S.
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* Mifepristone’s 25th anniversary: The article discusses the 25th anniversary of the FDA’s approval of mifepristone, an abortion pill, in the U.S.
* FDA Review: Robert Kennedy Jr. and FDA Commissioner Dr. Marty Makary have pledged a full review of the drug’s safety.
* Expanded Access: The FDA, under President Biden, expanded access to mifepristone in 2021 by permitting online prescriptions and mail-order delivery, a change abortion opponents are challenging.
* Generic Approval Delay: Evita Solutions applied to market a generic version of mifepristone four years ago, but it has not yet been approved. This is unusual, as generic drug approvals typically take 10 months.
* Normal Process: Advocates like Mini Timmaraju of Reproductive Freedom for All emphasize that the FDA’s approval process for generics is usually routine and relies on career scientists doing their jobs.
* Lack of Response: Evita solutions has not responded to requests for comment regarding the delay in their application.