Pfizer Incorporated / Wyeth Pharmaceuticals Inc. / Wyeth / Pratibha Rana Biostatistics Review Boris Zaslavsky / /
Country
Poland / Romania / Turkey / Austria / United States / Croatia / Columbia / Argentina / Mexico / New Zealand / /
Event
FDA Phase / /
IndustryTerm
manufacturing changes / disqualified site / manufacturing steps / manufacturing process / /
MedicalCondition
hemophilia A / severe hemophilia / hemophilia A. The / von Willebrand’s disease / Clinical Background Hemophilia A / deformity / moderately severe hemophilia A / deficiency / X-linked hereditary disorder / contractures / hemophilia / muscle atrophy / /
Summary Basis for Regulatory Action Date: [removed]From: Irwin M. Feuerstein, M.D., M.S., M.B.A., Chair of the BLA BLA/STN#: [removed]Applicant Name: Pfizer Incorporated / Wyeth Biopharma Division of Wyeth Pharmaceu