Posted by Michael Wonder on 17 Apr 2017
AMAG submits supplemental new drug application to FDA for Makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use
17 April 2017 - FDA decision anticipated on supplemental new drug application filing in the fourth quarter 2017.
AMAG Pharmaceuticals announced today that it has submitted a supplemental new drug application to the U.S. FDA for the Makena subcutaneous auto-injector, a drug-device combination product.
The current Makena intramuscular injection is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
