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May 24th, 2004

Octapharma receives FDA approval for OCTAGAM®
European Market Leader Now Available in U.S.


Octapharma AG announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to market OCTAGAM 5%, a liquid, ready-to-use, solvent/detergent treated immunoglobulin intravenous (IGIV) product.

”OCTAGAM has been a market leader in Europe for more than 10 years, and has been licensed in more than 50 countries world-wide.  This latest registration is an important milestone in the history of Octapharma and clearly demonstrates the acceptance of OCTAGAM as a truly global brand” said Wolfgang Marguerre, Chairman, Octapharma AG.

Under the terms of the FDA license, OCTAGAM is indicated for the treatment of primary immunodeficiency diseases (PID) and will be distributed in the United States by Octapharma USA, Inc.

Major Milestone
"The approval of OCTAGAM in the United States is a major milestone for Octapharma and extends our commitment to bringing the highest-quality IGIV products to patients around the world,” Tobias Marguerre, Area Manager, US, Canada & Mexico
“With an unmatched record of safety and reliability in Europe, OCTAGAM represents two decades of intensive investment in technology and process refinement made possible by Octapharma’s exclusive focus on human plasma products.

OCTAGAM is the first of a number of important and innovative plasma-derived therapeutics that Octapharma will introduce in the USA over the next several years.

OCTAGAM is the leading IGIV product in Europe.  According to the Marketing Research Bureau, which has monitored the plasma products industry since 1974, OCTAGAM held a 22 percent share of the European IGIV market in 2002, the largest of any licensed manufacturer.


Octapharma USA is located in Herndon, Virginia.  Ordering information for OCTAGAM is available by calling 1-800-826-6905.


The full press release can be viewed by clicking here.

Acrobat file PDF files require the free Adobe Acrobat Reader.

Please click here to see Full US Prescribing Information (Word document)


© Octapharma AG, 2004