On February 14, 2018, the FDA will announce its decision on whether or not to approve AMAG Pharmaceuticals Inc.’s (AMAG) Makena subcutaneous auto-injector, a drug-device combination product.Makena is an FDA-approved hormone medicine (progestin) prescribed to lower the risk of having a preterm baby in women pregnant with a single baby and who spontaneously delivered one preterm baby in the past. Currently, it is available as intramuscular injection formulation. Makena is a weekly injection.AMAG developed the Makena auto-injector with its device partner Antares Pharma Inc. (ATRS).AMAG closed Thursday’s (Jan.25) trading at $14.65, up 2.09%.