Review Memo - Categorical Exclusion - RiaSTAP
|FROM||Rebecca Olin , CSO, CBER/OCBQ/DMPQ/MRB2|
|THROUGH||John A. Eltermann, Jr. , R.Ph., M.S.,|
Director, DMPQ, HFM-670
|Applicant:||CSL Behring GmbH, License# 1765|
|PRODUCT||Human Fibrinogen Concentrate, Pasteurized|
|SUBJECT||Review Memo – Categorical Exclusion under 21 CFR 25.31(a) for Human Fibrinogen Concentrate, Pasteurized|
This is a request for a categorical exclusion from an Environmental Assessment under 21 CFR § 25.31(a).
This categorical exclusion request was submitted by CSL Behring as part of Biologics License Application 125317/0. The request for categorical exclusion has been reviewed and we conclude the request is justified because this submission involves a biological product that does not increase the use of the active moiety. Human Fibrinogen Concentrate (HFC) is fibrinogen (blood coagulation factor 1) that is isolated and purified from human plasma. Both fibrinogen and human plasma are substances that occur naturally in the environment. The final product container also contains human albumin, L-arginine hydrochloride, sodium chloride and sodium citrate; all naturally occurring substances. Other plasma products manufactured at the Marburg, Germany site include:
- Humate-P ®, Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, and
- Vivaglobin ®, Immune Globulin Subcutaneous (Human).
HFC has been manufactured at the Marburg site since 1956 and with the same process since 1986 for the European market. The main difference is that U.S. plasma is now being used instead of European plasma.
Rebecca Olin, CSO
John A. Eltermann, Jr., R.Ph., M.S.
Director, CBER, OCBQ, DMPQ