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
AMAG PHARMACEUTICALS (AMAG)
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Source: GlobeNewswire
WALTHAM, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (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 prefilled Makena auto-injector offers a new administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular (IM) Makena injection. “We are proud to deliver on back-to-back FDA approvals of our next-generation programs for both Makena and Feraheme, and look forward to maximizing the impact that these innovative products can deliver for patients and providers,” said William Heiden, AMAG’s president and chief executive officer. “Today’s approval provides a significant opportunity for us to extend the Makena franchise in 2
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