DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
December 19, 2001
Submission Tracking Number (STN): BL 101250/5006
Matthew E. Klamrzynski
100 Abbott Park Road
Abbott Park, IL 60064-3500
Dear Mr. Klamrzynski:
Your request to supplement your biologics license application for Auszyme Monoclonal (Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal to allow for a labeling change to extend the indications for use to include cadaveric serum specimen testing, has been approved.
This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.
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Hira L. Nakhasi, Ph.D.
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research