Reuters

Amag submits supplemental NDA for makena auto-injector

* 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 ...
Business Insider

AMAG Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for Makena® (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector

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 ...
Business Insider

AMAG Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee Meeting to Discuss the Results of the Makena PROLONG Trial

WALTHAM, Mass., Oct. 29, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug ...
The Pantagraph

Why AMAG Pharmaceuticals, Inc. and Antares Pharma, Inc. Are Soaring Today

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.