|
Product Approval
Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
Director
Division of Clinical Trials Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 12/20/2002
 Back
to Top 
Back to Index
Date created: September 25, 2003 |
