Reuters logo
2 months ago
BRIEF-Amag reports U.S. FDA acceptance of supplemental new drug application for Makena
June 26, 2017 / 12:40 PM / 2 months ago

BRIEF-Amag reports U.S. FDA acceptance of supplemental new drug application for Makena

June 26 (Reuters) - Amag Pharmaceuticals Inc:

* Amag announces U.S. FDA filing acceptance of supplemental new drug application for makena® (hydroxyprogesterone caproate injection) 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 that filing is subject to a standard 10-month review

* Amag Pharmaceuticals Inc - if makena auto-injector is approved, amag will request orange book listing of eligible antares patents, last of which expires in 2026

* Amag Pharmaceuticals Inc - ‍reaffirming 2017 financial guidance, including makena revenue guidance of $410 million to $440 million​ Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below