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Tag: makena

  • FDA pulls preterm-birth drug Makena and its generics from market after 12 years

    FDA pulls preterm-birth drug Makena and its generics from market after 12 years

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    The U.S. Food and Drug Administration said Thursday it had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment hit the market.

    The drug was approved in 2011 using the agency’s accelerated-approval pathway as a treatment to reduce the risk of spontaneous preterm birth in pregnant women who had a history of the condition.

    The…

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