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    FDA clears new generic abortion pill mifepristone amid political scrutiny

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    The US Food and Drug Administration (FDA) has given the green light to another generic version of mifepristone, the widely used abortion pill that has been at the center of political and legal fights across America.

    In a letter dated September 30, the FDA said it had approved a version made by Evita Solution, a privately held company that openly frames its mission as “normalizing abortion” and making the procedure “accessible to all.” Evita’s pill is a generic alternative to Danco Laboratories’ mifepristone, which has been on the market since 2000 for ending pregnancies of up to 10 weeks.

    This makes Evita the second private company selling a generic form of the drug, alongside GenBioPro, according to Reuters.

    The timing is significant. The approval comes just as abortion drugs are under fierce scrutiny. The FDA is reviewing the safety of mifepristone under pressure from conservative lawmakers and state attorneys general who argue the agency relaxed rules too far.

    US Health Secretary Robert F. Kennedy Jr. said in a post on X, the Biden administration “removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap.” He added that the FDA was legally bound to approve Evita’s generic since federal law requires approval if the drug is proven identical to the brand-name version.

    For its part, the FDA has stood firmly behind the medication. It points to decades of use by millions of women in the US and abroad, calling mifepristone “extremely safe” and stressing that “serious adverse events are exceedingly rare.”

    Mifepristone works by blocking progesterone, the hormone that helps maintain the uterine lining in pregnancy. Patients then take misoprostol to complete the process.

    Still, the politics of access remain complicated. Just last month, Costco said it would not stock mifepristone in its US pharmacies, citing low demand.

    – Ends

    Published By:

    Aashish Vashistha

    Published On:

    Oct 3, 2025



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