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Vaccines, Blood & Biologics

Categorical Exclusion under 21 CFR 25.31(c) - Voluven

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

To: NDA STN BN070012

From: Janie Russell, HFM-676

Subject: Categorical Exclusion under 21 CFR 25.31(c)

Date: July 27, 2007

I have reviewed pertinent sections of the New Drug Application (STN BN070012) from Fresnius Kabi for the manufacture of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride infusion (Voluven), a plasma substitute for the treatment of hypovolemia, 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 drug (plasma substitute) 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.


/Janie Russell/
Janie Russel
Committee Facility reviewer for the BLA


/John A. Eltermann, Jr., R.Ph., M.S./
John A. Eltermann, Jr., R.Ph., M.S.
Division of Manufacturing and Product Quality


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