Hydroxyprogesterone - AMAG Pharmaceuticals

Drug Profile

Hydroxyprogesterone - AMAG Pharmaceuticals

Alternative Names: 17 α-hydroxyprogesterone caproate; 17-AHPC; 17-OHPC; 17P; Gestiva; Hydroxyprogesterone caproate; Hydroxyprogesterone caproate injection; Hydroxyprogesterone long-acting; Makena; Makena QuickShot Auto Injector; Makena SQ

Latest Information Update: 05 Jul 2017

Price : $50

At a glance

  • Originator Cytyc Prenatal Products
  • Developer AMAG Pharmaceuticals
  • Class Pregnenediones; Progesterone congeners; Small molecules
  • Mechanism of Action Progesterone receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Preterm labour
  • New Molecular Entity No

Highest Development Phases

  • Marketed Preterm labour

Most Recent Events

  • 26 Jun 2017 FDA assigns PDUFA action date 14/02/2018 for hydroxyprogsterone (subcutaneous autoinjector) for Preterm labour
  • 26 Jun 2017 US FDA accepts sNDA for Preterm labour (Subcutaneous autoinjector) for review
  • 17 Apr 2017 AMAG Pharmaceuticals intends to launch hydroxyprogesterone subcutaneous auto-injector in 2018
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