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Vaccines, Blood & Biologics

Filing Meeting Memo - April 29, 2009 - Prevnar 13

Re:STN 125324
Title:Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Sponsor: Wyeth Pharmaceuticals Inc.
Date:April 29, 2009
To: File

Julienne Vaillancourt, R.Ph., M.P.H.
Review Committee Chair


In lieu of a formal BLA filing meeting, disciplined reviewers communicated their filing recommendations to me via e-mail between April 21 and April 28, 2009.  No refuse-to-file issues were identified, and therefore, all disciplined reviewers recommended filing the BLA.  However, some reviewers indicated that they had identified review issues during their preliminary review of the BLA for filing.  A complete list of all such identified deficiencies is pending.  Thus, the BLA will be filed and the filing letter will include language noting that identified deficiencies will be communicated to the sponsor in a separate letter on or by June 13, 2009.

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