Pfizer (PFE)

Pfizer 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.

Dec 31 · 1:38:00 PM · Source: Reuters
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by Michael Oliveto