|
US Food & Drug Administration approves Privigen(TM) |
|
|
|
28 Jul 2007 |
CSL Limited announced today that its subsidiary CSL Behring, has been granted marketing approval from the U.S. Food and Drug Administration (FDA) for PrivigenTM [Immune Globulin Intravenous (Human) 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI)
MELBOURNE, Australia | July 27, 2007 | CSL Limited announced today that its subsidiary CSL Behring, has been granted marketing approval from the U.S. Food and Drug Administration (FDA) for PrivigenTM [Immune Globulin Intravenous (Human) 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.
A 10 percent liquid preparation of polyvalent human immunoglobulin, Privigen offers healthcare professionals convenience and ease-of-use. It is the first and only prolinestabilized IVIg that is always ready for immediate use, requiring no refrigeration or reconstitution.
CSL Behring plans to launch Privigen in the first quarter of 2008, which is consistent with previous expectations. In the meantime, the company is advancing the registration of Privigen in Europe. The application is currently under review by European regulatory authorities.
SOURCE: CSL Limited |
