AMAG Pharmaceuticals Announces FDA Approval of Makena

AMAG Pharmaceuticals (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.

As quoted in the press release:

“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 2018 and beyond. We have been preparing for this approval for months and are poised to execute on our aggressive launch plans, leveraging deep relationships with providers and payers in the maternal health space to bring this important therapy to at-risk pregnant women.”

Click here to read the full press release.