Astellas' menopause drug hit by FDA delay after spending $97M on a priority review voucher
In August, Astellas announced that an application for its menopausal symptom drug fezolinetant had been accepted, and it used a priority review voucher — to which it ascribed a $97 million value — to speed up the process by four months.
The original decision deadline was Feb. 22, but today the Japanese pharma announced that the FDA is extending the original PDUFA date by three months to May 22.
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