Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
August 28, 2002
Our STN: BL 103792/5008
Robert L. Garnick, Ph.D.
1 DNA Way
South San Francisco, CA 94080
Dear Dr. Garnick:
Your request to supplement your biologics license application for Trastuzumab to revise the package insert to include Vysis PathVysion HER2 DNA Probe, a FISH test for detecting HER2 gene amplification as a method to select patients for therapy, has been approved.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).
This information will be included in your biologics license application file.
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Karen D. Weiss, M.D.
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 12/10/2002
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Date created: September 25, 2003