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 Product Approval Information - Licensing Action

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

February 9, 2000

Our Reference No.: 99-1390

Robert L. Garnick, Ph.D.
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990

Dear Dr. Garnick

Your request to supplement your biologics license application for Trastuzumab to include proposed label changes to the package insert, product container, and package to clarify the instructions for reconstitution, has been approved.

We acknowledge your written commitment of February 3, 2000, to develop a 20 mL diluent vial to be packaged with this product. We understand that the first lot will be filled and placed on stability by March 2000.

Please submit final printed labeling at the time of use and include implementation information on FDA Form 2567. 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 ---

Kathryn E. Stein, Ph.D.
Division of Monoclonal Antibodies
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

Last Updated: 1/15/2001


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Date created: September 25, 2003

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