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FDA clears AMAG's single-dose Makena

Feb. 23, 2016 1:17 PM ETAMAG Pharmaceuticals, Inc. (AMAG) StockBy: Douglas W. House, SA News Editor1 Comment
  • The FDA approves AMAG Pharmaceuticals' (NASDAQ:AMAG +1.1%) single-dose preservative-free formulation of Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in pregnant women who have a history of preterm birth. The clearance is a good turnaround from the CRL the company received in November.
  • Commercialization will commence in Q2.
  • Makena was originally cleared in a multi-dose vial format in February 2011.
  • Previously: AMAG Pharma receives CRL for single-dose Makena; shares off 11% premarket (Nov. 19, 2015)

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