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Hydroxyprogesterone - AMAG Pharmaceuticals

Drug Profile

Hydroxyprogesterone - AMAG Pharmaceuticals

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

Latest Information Update: 12 Apr 2023

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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

  • No development reported Preterm labour

Most Recent Events

  • 07 Mar 2023 Withdrawn for Preterm labour (Prevention) in USA (IM)
  • 07 Mar 2023 Withdrawn for Preterm labour (Prevention) in USA (SC)
  • 19 Oct 2022 The Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) voted to recommend withdrawal of approval of Hydroxyprogesterone injection (Makena®) in USA
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