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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Statistical Review and Evaluation for Sponsor’s Response- BLA - TachoSil, December 15, 2009





Public Health Service

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Biostatistics and Epidemiology
Division of Biostatistics

Statistical Review and Evaluation for Sponsor’s Response- BLA

BLA/Supplement Number:125351/0/4
Product Name:Thrombin, Fibrinogen, patch
Indication(s):-------------------------------(b)(4)-------------------------------- an adjunct to hemostasis in cardiovascular surgery
Applicant:Nycomed DANMARK APS/1825
Date(s):CBER Receipt Date: 15-Dec-2009
Review Priority:Standard
Statistical Branch:Therapeutics Evaluation Branch
Primary Statistical Reviewer:Chunrong Cheng, Ph.D./HFM-219
Concurring Reviewer:Jessica Kim, Ph.D., Team Leader
Therapeutic Evaluation Branch/HFM-219
Ghanshyam Gupta, Ph.D., Branch Chief
Therapeutic Evaluation Branch/HFM-219
Medical Office/Division:OBRR/DH/CRB
Clinical Reviewer(s):Kimberly Lindsey, MD./HFM-392
Project Manager:Jie He/HFM-380

In this submission, the sponsor provided responses to CBER’s information request.
FDA comment #1

Five (5) Pages Determined to be Non-Releasable:  (b)(4)