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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

May 15, 2002

Our STN: BL 103172/5009

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

Dear Dr. Garnick:

Your request to supplement your biologics license application for Alteplase, to revise the package insert to include adding information regarding orolingual angioedema to the Precautions and Adverse Reactions sections, and bolding a statement in the Dosage and Administration section, has been approved.

Please submit all 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 ---

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: 5/17/2002

 

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Date created: September 25, 2003

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