Posted by Michael Wonder on 25 Sep 2021
Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review period for the biologics license application for somatrogon, a once-weekly long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency in paediatric patients.
The Prescription Drug User Fee Act goal date has been extended by three months to January 2022, as a result of Pfizer’s submission of additional data to the original biologics license application.
