Pfizer Inc. Says FDA Delays Prevnar Review For Three Months

Pfizer Inc. said Friday that U.S. regulators will take another three months to consider approving its Prevnar 13 pneumococcal vaccine for use in adults. Pfizer said the Food and Drug Administration now expects to make a decision by January 2012. The agency will use the time to consider additional data submitted by Pfizer that supports the use of the vaccine in adults age 50 and older. Prevnar 13 is the world’s biggest-selling vaccine. It brought Pfizer $3.7 billion in worldwide revenue in 2010, and an expanded marketing approval would boost its sales. That would help make up for the loss of revenue from other products like the cholesterol drug Lipitor, which loses patent protection Nov. 30.

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