Makena approved for prevention of preterm birth

Hologic announced that the FDA has approved Makena (hydroxyprogesterone caproate injection), formerly known as Gestiva, to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. This approval was based on a study of 463 women who had experienced a previous singleton spontaneous preterm birth.

Study data showed improvement in the proportion of women who delivered <37 weeks of gestation when treated with Makena. While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth.  It is not intended for use in women with multiple gestations or other risk factors for preterm birth. 

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