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Primary Immunodeficiency Syndrome News
Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency
Posted 16 Sep 2016 by Drugs.com
Lexington, Mass. – September 14, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the United States Food and Drug Administration (FDA) has granted approval for Cuvitru [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. Cuvitru is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disor ...
FDA Medwatch Alert: Bivigam Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed
Posted 8 Apr 2013 by Drugs.com
[Posted 04/05/2013] ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of Bivigam Immune Globulin Intravenous (Human), 10% Liquid. Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles. BACKGROUND: Bivigam is indicated ...
Posted 29 Dec 2012 by Drugs.com
DREIEICH, Germany and BOCA RATON, Fla., Dec. 20, 2012 /PRNewswire/ – Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA). Bivigam is the first polyspecific intravenous immune globulin manufactured in the U.S. by Biotest ...
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 ...
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 ...
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Hizentra, Gammagard, Gamunex, Carimune, Privigen, Hyqvia, Gamunex-C, Vivaglobin, immune globulin intravenous, view more... Cuvitru, immune globulin subcutaneous, Carimune NF, Octagam, Sandoglobulin, Panglobulin, Gammaplex, Gammaked, immune globulin intravenous and subcutaneous, Bivigam, hyaluronidase / immune globulin, Flebogamma, Gammar IV, Panglobulin NF, Iveegam En, Gammagard S / D, Gamimune, Gammar-P IV, Polygam S / D, Gamimune N 5%, Venoglobulin-S 5%, Gamimune N 10%, Venoglobulin-S 10%