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. 

For more information visit www.hologic.com.