Estradiol vaginal - TherapeuticsMD

Drug Profile

Estradiol vaginal - TherapeuticsMD

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

Latest Information Update: 22 Sep 2016

Price : $50

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.

  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Atrophic vaginitis

Most Recent Events

  • 19 Sep 2016 FDA assigns PDUFA action date of 07/05/2017 for estradiol vaginal for Atrophic vaginitis
  • 19 Sep 2016 The US FDA accepts NDA for estradiol vaginal for Atrophic vaginitis for review
  • 01 Aug 2016 Final pharmacokinetics data from the REJOICE sub-study in Atrophic vaginitis (vulvar and vaginal atrophy due to menopause) presented at The 98th Annual Meeting of the Endocrine Society (ENDO-2016)
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