Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
June 5, 2003
Our STN: BL 103795 / 5109
One Amgen Center Drive
Thousand Oaks , CA 91320
Dear Mr. Hunt:
Your request to supplement your biologics license application for Etanercept to revise the package insert to include information regarding concurrent Etanercept and Anakinra therapy 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.
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Patricia Keegan, M.D.
Division of Clinical Trials Design
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 6/17/2003
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Date created: September 25, 2003