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 Product Approval Information - Licensing Action

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

November 12, 2002

Our STN: BL 103628/5008

Biogen, Incorporated
Attention: Nadine Cohen, Ph.D.
Vice President, Regulatory Affairs
14 Cambridge Center
Cambridge, MA 02142

Dear Dr. Cohen:

Your request to supplement your biologics license application for Interferon beta-1a, to revise the package insert to include updated information regarding serum neutralizing antibodies, 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 Weiss, M.D.
Division of Clinical Trials Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research


Last Updated: 12/20/2002


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Date created: September 25, 2003

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