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Wyeth Submits Prevnar 13 BLA

Wyeth submitted a BLA to the FDA for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Wyeth submitted a BLA to the FDA for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein). The FDA granted Prevnar 13 Fast Track designation last year, which is designed to facilitate review of products that address serious conditions for which there is an unmet medical need. The submission includes data from 13 Phase III studies involving more than 7,000 infants and young children. Prevnar 13 is designed to protect against the 13 most prevalent serotypes associ...

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