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Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid for Patients with Primary Immunodeficiency
Posted 25 Jul 2011 by Drugs.com
DEERFIELD, Ill.--(BUSINESS WIRE)--Jul 25, 2011 - Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of Gammagard Liquid 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency (PI). The approval of this new route of administration will allow physicians and PI patients to work together to determine which route of administration of Gammagard Liquid is most appropriate. Subcutaneous use of Gammagard Liquid allows patients to self-administer their therapy at home on a weekly basis. "The FDA approval of a subcutaneous route of administration for Gammagard Liquid offers PI patients the option to administer Gammagard Liquid either intravenously or subcutaneously, depending on their individual needs," said Richard Schiff, M.D., Ph.D., medical director for Baxter's gammaglobulin trials. ... Read more
Related support groups: Gammagard, Primary Immunodeficiency Syndrome, Gammagard S/D
Talecris Biotherapeutics Receives FDA Approval for Gamunex-C
Posted 17 Oct 2010 by Drugs.com
RESEARCH TRIANGLE PARK , N.C., Oct. 14 /PRNewswire-FirstCall/ – Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI). The newly approved Gamunex-C provides both the intravenous route of administration and a new subcutaneous route of administration. The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP). The subcutaneous mode is approved to treat only PI. The difference between Gamunex and Gamunex-C is the labeling and packaging information. Gamunex-C labeling describes both the intravenous and subcutaneous routes of administration, whereas Gamunex labeling ... Read more
Related support groups: Gamunex, Primary Immunodeficiency Syndrome, Immune Globulin Subcutaneous
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Gammagard, Gamunex, Sandoglobulin, Vivaglobin, Flebogamma, Hizentra, Polygam S/D, Octagam, Carimune, view more... Gamunex-C, immune globulin subcutaneous, Privigen, Gamimune, Gammaplex, Carimune NF, Gamimune N 10%, Venoglobulin-S 5%, Gammagard S/D, Panglobulin NF, immune globulin intravenous and subcutaneous, Venoglobulin-S 10%, Gammar-P IV, Panglobulin, immune globulin intravenous, Gamimune N 5%, Iveegam En