Posted by Michael Wonder on 09 Feb 2017
FDA approves Bio Products Laboratory's Gammaplex 10% for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura
8 February 2017 - Bio Products Laboratory today announced that the U.S. FDA has approved Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura in adults.
Gammaplex 10% is made with the same process as Bio Products Laboratory previously approved intravenous immunoglobulin (IVIG) treatment, Gammaplex 5% (immune globulin intravenous [human], 5% liquid).
Gammaplex 10% is more concentrated than Gammaplex 5%, with an immune globulin G concentration of 100g/L, and is stabilised with glycine.
