Posted by Michael Wonder on 15 Feb 2018
AMAG Pharmaceuticals announces FDA approval of Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector to reduce the risk of preterm birth in certain at-risk women
14 February 2018 - Marks second FDA approval for AMAG this month
AMAG Pharmaceuticals today announced that the U.S. FDA approved the Makena subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past.
The pre-filled Makena auto-injector offers a new administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular Makena injection.
