Posted by Michael Wonder on 14 Jun 2021
Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency
11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to 25 September 2021.
Ascendis Pharma today announced that the U.S. FDA notified the Company that information the Company submitted in connection with the FDA’s on=going review of the biologics license application for lonapegsomatropin for the treatment of paediatric growth hormone deficiency constituted a major amendment to the application.
