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FDA Approves Generic Mifepristone Amid Political Scrutiny
The US Food and Drug Administration (FDA) has approved a generic version of mifepristone by Evita Solution, expanding access to the widely used abortion pill amid political and legal controversies.
Evita Solution, a privately held company, aims to “normalize abortion” and make the procedure “accessible to all.” Their generic alternative joins GenBioPro, which also sells a generic form of mifepristone alongside Danco Laboratories’ original product, on the US market.
The approval comes at a tense time. Abortion drugs are under intense political and legal scrutiny, with conservative lawmakers and state attorneys general questioning the FDA’s rules on in-person dispensing.
US Health Secretary Robert F. Kennedy Jr. stated that the Biden administration is “filling the gap” by reviewing the drug’s safety, though federal law requires the FDA to approve Evita’s generic since it is proven identical to the brand-name version.
The FDA maintains mifepristone is extremely safe, citing decades of use and noting that serious adverse events are exceedingly rare. Mifepristone blocks progesterone, a hormone crucial for maintaining pregnancy, followed by misoprostol to complete the termination process.
Despite regulatory clearance, access remains politically charged. Last month, Costco announced it would not stock mifepristone in its US pharmacies, citing low demand.
The FDA’s approval of Evita’s generic mifepristone marks a key moment in reproductive healthcare access, even as debates continue over safety, regulation, and political oversight.
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Published: Oct 03, 2025
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