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BioWorld - Tuesday, December 30, 2025
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Home » Nothing flashy: FDA approves Astellas’ menopause drug
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Nothing flashy: FDA approves Astellas’ menopause drug

May 15, 2023
By Lee Landenberger
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
BioWorld Regulatory Genitourinary/sexual function Women's health U.S. FDA

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