Posted by Michael Wonder on 28 Apr 2021
FDA begins review of GC Pharma’s blood product for marketing authorisation
27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for regulatory clearance, with the date of review completion set on 25 February 2022, the Korean company said on Tuesday.
GC Pharma submitted its biologics license application for the therapy to the FDA in February. In general, the FDA has a 60 day filing review period to determine whether GC Pharma’s application is complete and acceptable for filing.
According to GC Pharma, GC5107 is a blood product used for the treatment of congenital immunodeficiency disorder and immune thrombocytopenia.
