FDA approves Octagram 10% for ITP - Octapharma
Octapharma USA announced that the FDA has approved Octagam 10% (immunogGlobulin Intravenous liquid) for the treatment of adults with Chronic Immune Thrombocytopenic Purpura (ITP). Octagam 10% is a solvent/detergent treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma.
The drug was first approved in the US in 2006 but was subsequently withdrawn due to unexpectedly high number of reports of serious thromboembolic events. The new approval of Octagam 10% is based on the results of an Octapharma-sponsored clinical trial to evaluate the safety and efficacy of Octagam 10% in 66 patients ages 17�88 years old with chronic ITP.
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