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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: 07 Nov 2019

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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

  • 30 Oct 2019 Bone, Reproductive and Urologic Drugs Advisory Committee recommends withdrawal of approval of hydroxyprogesterone in the US
  • 08 Mar 2019 Top-line efficacy and adverse events data from the phase III PROLONG trial in Preterm labour released by AMAG Pharmaceuticals
  • 30 Mar 2018 Launched for Preterm labour (Prevention) in USA (SC) before May 2018
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