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BRIEF-Amag submits supplemental NDA for makena auto-injector
April 17, 2017 / 12:31 PM / 7 months ago

BRIEF-Amag submits supplemental NDA for makena auto-injector

April 17 (Reuters) - Amag Pharmaceuticals Inc

* Amag submits supplemental new drug application to FDA for makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use

* 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 of eligible antares patents, last of which expires in 2026 Source text for Eikon: Further company coverage:

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