* Anticipates a six-month FDA review timeline with potential for approval and launch in Q4 of 2017 * Amag Pharmaceuticals - if makena auto-injector is approved, Amag will request orange book listing ...

WALTHAM, Mass., June 26, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug ...

Makena SC auto-injector revenue grew to $41.0 million, compared with $13.5 million in the same period last year (launched March 2018). The company did not ship any Makena IM product during the quarter ...

AMAG announced Thursday that the FDA has approved it's Makena subcutaneous auto-injector drug-device combination product. Makena is a drug used to reduce the risk of preterm birth in at-risk women.