FDA Rejects Gardasil for Use in Older Women

FDA Rejects Gardasil for Use in Older Women

A vaccine for cervical cancer, Gardasil was rejected by the US Food and Drug Administration (FDA) for use in women aged 27 and over. The vaccine was developed by an Australian Company, CSL.

The vaccine is marketed outside Australia by a pharmaceutical company, Merck& Co Inc. The company has said that its application to extend the use of the vaccine was rejected by the US FDA. The FDA has claimed that there are not enough evidences to show that Gardasil prevents HPV-related cervical cancer in women older than 27. Merck has been waiting for the approval of FDA so that it can sell the vaccine in US.

The vaccine is known to prevent cervical cancer in women by preventing them against major strains of Human Papilloma Virus (HPV). The HPV is said to be the main cause of cervical Cancer.

Merck has earned nearly $US1.4 billion from the sale of Gardasil in 2008. In 2009 the sale of vaccine dropped to $US988 million. CSL earns royalty payments from the sale of vaccine outside Australia. In 2010, the royalty payment was $102 million which was less than the previous year. The sale of vaccine also fell in Australia after the first round of vaccination. The shares of CSL had also fallen 0.22 % to $36.46.

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