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CSL Biotherapies Announces FDA Marketing Approval of its Monovalent Pandemic (H1N1) 2009 Influenza A Vaccine
Date:9/16/2009

CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics licensing application for licensure of its monovalent pandemic (H1N1) 2009 influenza A vaccine for active immunization of persons age 18 years and older against influenza disease caused by the H1N1 virus.

King of Prussia, PA (PRWEB) September 16, 2009 -- CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics licensing application for licensure of its monovalent pandemic (H1N1) 2009 influenza A vaccine for active immunization of persons age 18 years and older against influenza disease caused by the H1N1 virus.

"The FDA's licensure of our H1N1 vaccine is a significant milestone in CSL's efforts to bring an effective pandemic influenza vaccine to the U.S. and Southern hemisphere markets," said Paul Perreault, President, CSL Biotherapies. "We're pleased to have contributed important clinical trial data on this vaccine to regulatory authorities in the United States and Australia. CSL Biotherapies will continue to work closely with the U.S. government to supply pandemic H1N1 vaccine as quickly as possible in order to assist in national efforts to protect the health of Americans."

CSL Biotherapies has an initial contract worth $180 million to deliver bulk H1N1 vaccine antigen to the U.S. Health and Human Services Department (HHS), wit
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