Categorical Exclusion Memo - Wilate, November 19, 2009
|To:||BLA STN 125251/0|
|From:||Marion Michaelis, Reviewer, CBER/OCBQ/DMPQ/MRB2, HFM-676|
|To:||John A. Eltermann, Jr., R.Ph., M.S., Director, DMPQ, HFM-670|
|Through:||Chiang Syin, PhD, Branch Chief, CBER/OCBQ/DMPQ/MRB2, HFM-676|
|Subject:||Memo - Categorical Exclusion under 21 CFR 25.31(c) for Biologics License Application (BLA) for von Willebrand Factor Concentrate (Human) [Wilate] manufactured at Octapharma Pharmazeutika Produktionsges.m.b.H - [License No. 1646], Vienna, Austria location.|
|Date:||November 19, 2009|
I have reviewed pertinent sections of the Biologics License Application (STN 125251/0) from Octapharma Pharmazeutika Produktionsges.m.b.H. for the manufacture of Coagulation Factor VIII/von Willebrand Factor Complex (Human), and find that the request for a categorical exclusion from an environmental assessment under 21 CFR 25.31(c) is justified because the product is composed of naturally occurring substances, the manufacture or use of the product will not alter significantly the concentration or distribution of the substance, its metabolites or degradation products, and no extraordinary circumstances exist. This determination applies to all manufacturing locations associated with this application.
Marion Michaelis, Reviewer
Chiang Syin, PhD
Branch Chief, CBER/OCBQ/DMPQ/MRB2
John A. Eltermann, Jr., R.Ph., M.S.