Pfizer Inc.

Pfizer Provides U.S. Regulatory Update On Prevnar 13(TM) Vaccine

Published in Medical Letter on the CDC and FDA, January 17th, 2010

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13™, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company's candidate 13-valent pneumococcal conjugate vaccine. As a result, the review will continue beyond the prescription drug user fee (PDUFA) action date of December 30, 2009.

"We remain confident that the data in the BLA support the approval of Prevnar 13," says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. "We will continue to work closely with the FDA to help expedite the completion of its...

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Source: Medical Letter on the CDC and FDA (2010-01-17)

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