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Bijuva Approval History

FDA Approved: Yes (First approved October 28, 2018)
Brand name: Bijuva
Generic name: estradiol and progesterone
Dosage form: Capsules
Previous Name: TX-001HR
Company: TherapeuticsMD, Inc.
Treatment for: Perimenopausal Symptoms, Postmenopausal Symptoms

Bijuva (estradiol and progesterone) is a bio-identical hormone combination for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) due to menopause.

Development History and FDA Approval Process for Bijuva

DateArticle
Oct 29, 2018Approval FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
Mar  8, 2018TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR
Dec 28, 2017TherapeuticsMD Announces Submission of New Drug Application for TX-001HR

Further information

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