Estradiol vaginal - TherapeuticsMD

Drug Profile

Estradiol vaginal - TherapeuticsMD

Alternative Names: Estradiol VagiCap™; TX- 12-004-HR; TX-004HR; VagiCap; Yuvvexy

Latest Information Update: 21 Dec 2017

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At a glance

  • Originator TherapeuticsMD
  • Class Antineoplastics; Estradiol congeners; Estrenes; Hormonal replacements; Hormones; Pregnenediones; Small molecules
  • Mechanism of Action Estrogen receptor agonists
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Atrophic vaginitis

Most Recent Events

  • 19 Dec 2017 FDA assigns PDUFA action date of 29/05/2018 for Estradiol vaginal for Atrophic vaginitis
  • 19 Dec 2017 US FDA accepts NDA resubmission for estradiol vaginal for Atrophic vaginitis for review
  • 29 Nov 2017 TherapeuticsMD re-submits NDA to the US FDA for estradiol vaginal for Atrophic vaginitis
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