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Product Approval Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
May 2, 2003
Our STN: BL 103780/5010
Pamela Williamson Joyce
Serono, Incorporated
One Technology Place
Rockland, MA 02370
Dear Ms. Williamson Joyce:
Your request to supplement your biologics license application for Interferon beta-1a to revise the package insert based on the 48 week results from the final study report for study 21125 has been approved.
This fulfills your commitment to submit a final study report, data sets and modified labeling based on 48-week results from study 21125 by June 2002 as stated in commitment number 7 of the March 7, 2002 approval letter.
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). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by an FDA Form 2253.
All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.
This information will be included in your biologics license application file.
Sincerely yours,
--- signature ---
Patricia Keegan, M.D.
Acting Director
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Updated July 31, 2003
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Date created: September 25, 2003 |
