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Imvexxy FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved May 29, 2018)
Brand name: Imvexxy
Generic name: estradiol
Dosage form: Vaginal Inserts
Previous Name: TX-004HR
Company: TherapeuticsMD, Inc.
Treatment for: Dyspareunia

Imvexxy (estradiol) is a bio-identical 17β-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

Development timeline for Imvexxy

DateArticle
May 30, 2018Approval TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause
Dec 19, 2017TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR
Nov 29, 2017TherapeuticsMD Announces Resubmission of New Drug Application for TX-004HR
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)

Further information

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