Posted by Michael Wonder on 05 May 2021
US FDA accepts GC Pharma’s biologics license application for immunoglobulin 'GC5107'
5 May 2021 - A significant milestone towards entering the world's largest plasma product marketplace.
GC Pharma today announced that the United States FDA accepted the the company’s biologics license application for 'GC5107 (Immune Globulin Intravenous (Human),10% Liquid)’ intended for the treatment of primary humoral immunodeficiency, a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.
The Prescription Drug User Fee Act goal date for a decision by the FDA on the application is in February 2022.
