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Astellas Pharma Submits Fezolinetant NDA To FDA

Astellas Pharma Inc. said that it has submitted new drug application for fezolinetant to the U.S. Food and Drug Administration.

Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms or VMS associated with menopause.

VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

The company noted that it is reviewing the financial impacts of the submission for the fiscal year ending March 31, 2023.

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