FDA Grants Priority Review Status to Prevnar 13 Marketing Application
Thu, 05/07/2009 - 4:36am
Wyeth Pharmaceuticals, a division of Wyeth, announced today that the FDA granted priority review to the company's Biologic LicenseApplication (BLA) for Prevnar 13…, Pneumococcal 13-valent Conjugate Vaccine(Diphtheria CRM(197) Protein), which was submitted on March 31. Priorityreview designation is given to products that, if approved, would be asignificant therapeutic or public health advance. Based on this designation,Wyeth expects a regulatory decision within six months.