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Yuvvexy Approval Status

  • FDA approved: No
  • Brand name: Yuvvexy
  • Generic name: estradiol
  • Previous name: TX-004HR
  • Company: TherapeuticsMD, Inc.
  • Treatment for: Dyspareunia

Yuvvexy (estradiol) is an investigational bio-identical 17β-estradiol softgel capsule vaginal formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

Development Status and FDA Approval Process for Yuvvexy

DateArticle
May  8, 2017TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application
Apr 19, 2017TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update
Apr 10, 2017TherapeuticsMD Provides TX-004HR Regulatory Update
Sep 19, 2016TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR)
Jul  7, 2016TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR)

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