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FDA Misses Action Date for Pfizer’s Prevnar 13

The FDA has not yet completed its review of the BLA for Prevnar 13, Pfizer’s13-valent pneumococcal conjugate vaccine.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has not yet completed its review of the BLA for Prevnar 13, Pfizer’s13-valent pneumococcal conjugate vaccine. The review had a 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,” said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer. “We will continue to work closely with the FDA to help expedite the completion of its review of our BLA.” In May 2009, Prevnar 13...

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