The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate)
injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women
with a history of at least one spontaneous preterm birth.
The drug is not intended
for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for
The FDA approved Makena under the agency’s accelerated approval
regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here,
reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a
A health care provider would give Makena once a week by injection
into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy.
For more information, please visit: Makena