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Gepirone ER - Fabre-Kramer Pharmaceuticals

Drug Profile

Gepirone ER - Fabre-Kramer Pharmaceuticals

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

Latest Information Update: 11 Jan 2018

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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
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Major depressive disorder

Most Recent Events

  • 03 Jan 2018 Fabre-Kramer Pharmaceuticals and Mission Pharmacal enter into a manufacturing agreement for the registration batches of Gepirone ER
  • 03 Jan 2018 Fabre-Kramer Pharmaceuticals plans to submit the NDA amendment for Gepirone ER to the US FDA for review and approval in second half of 2018.
  • 21 Sep 2017 Gepirone ER is still preregistered for Major depressive disorder in USA (Fabre-Kramer Pharmaceuticals pipeline, September 2017)
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