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 Product Approval 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.
Genentech, Incorporated
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.

Sincerely yours,
--- signature ---

Karen D. Weiss, M.D.
Director
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

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