BRIEF-Amag reports U.S. FDA acceptance of supplemental new drug application for Makena [Reuters]
AMAG PHARMACEUTICALS (AMAG)
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Source: Reuters
BRIEF-Amag reports U.S. FDA acceptance of supplemental new drug application for Makena June 26 Amag Pharmaceuticals Inc: * Amag announces U.S. FDA filing acceptance of supplementalnew drug application for makena® (hydroxyprogesterone caproateinjection) subcutaneous auto-injector * Amag Pharmaceuticals Inc - prescription drug user fee act(pdufa) target action date of february 14, 2018 * Amag Pharmaceuticals Inc - FDA has now determined thatfiling is subject to a standard 10-month review * Amag Pharmaceuticals Inc - if makena auto-injector isapproved, amag will request orange book listing of eligibleantares patents, last of which expires in 2026 * Amag Pharmaceuticals Inc - ?reaffirming 2017 financialguidance, including makena revenue guidance of $410 million to$440 million?Source text for Eikon:Further company coverage:
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