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Veozah FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 1, 2024.

FDA Approved: Yes (First approved May 12, 2023)
Brand name: Veozah
Generic name: fezolinetant
Dosage form: Tablets
Company: Astellas Pharma US, Inc.
Treatment for: Menopausal Disorders, Hot Flashes

Veozah (fezolinetant) is a selective neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Development timeline for Veozah

DateArticle
Sep 12, 2024FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause
May 13, 2023Approval FDA Approves Veozah (fezolinetant) for the Treatment of Vasomotor Symptoms Due to Menopause
Mar 13, 2023Results from Astellas' Pivotal Phase 3 SKYLIGHT 1™ Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet
Feb 20, 2023Astellas Provides Update on Fezolinetant New Drug Application in U.S.
Aug 18, 2022U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Jun 23, 2022Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Mar  7, 2022Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause
Feb 19, 2021Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women
Aug  6, 2019Astellas Initiates Phase 3 Clinical Trials for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms
Mar 26, 2019Astellas Presents Fezolinetant Phase 2b Clinical Trial Results at Endocrine Society's Annual Meeting (ENDO)

Further information

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