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FDA announces decision to withdraw Makena (hydroxyprogesterone caproate)

April 6, 2023 -The FDA announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate). Makena and its generics are not shown to be effective for reducing the risk of preterm birth in women with singleton pregnancy who have a history of singleton spontaneous preterm birth. Additionally, Makena and its generics have not been shown to be effective for any subgroup of this population, including in women at high risk of preterm birth. The benefits of Makena do not outweigh the risks.

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