Gepirone ER

Drug Profile

Gepirone ER

Alternative Names: BMY 13805; MJ 13805; Org 33062; TGFK07AD; Variza™

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Bristol-Myers Squibb
  • Developer Fabre-Kramer Pharmaceuticals
  • Class Antidepressants; Anxiolytics; Hypnosedatives; Pyrimidines; Small molecules
  • Mechanism of Action Serotonin 1A receptor agonists
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Major depressive disorder

Most Recent Events

  • 17 Mar 2016 US FDA Office of New Drugs rule favourably on efficacy of Gepirone ER
  • 02 Dec 2015 The US FDA completes review of the amended NDA submitted by Fabre-Kramer for Major depressive disorder
  • 20 Oct 2009 Gepirone ER is available for licensing (http://www.fabrekramer.com)
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