Posted by Michael Wonder on 20 Feb 2023
Astellas provides update on fezolinetant new drug application in US
20 February 2023 - Astellas Pharma today announced the US FDA notified the company that it is extending the original priority review PDUFA goal date for fezolinetant, an investigational agent for the treatment of moderate to severe vasomotor symptoms due to menopause.
Astellas was notified on 17 February 2023, that the FDA is extending the PDUFA goal date by three months, to 22 May 2023, to allow more time to complete their review.
