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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
February 19, 2002
Our STN: BL 103737/5005
Alice Wei
IDEC Pharmaceuticals Corporation
3030 Callan Road
San Diego, CA 92121
Dear Ms. Wei:
Your request to supplement your biologics license application for
Rituximab to revise the dosage and administration section of the
package insert to include information regarding the use of Rituximab
as a component of the Zevalin therapeutic regimen 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: 3/5/2002
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Date created: September 25, 2003 |
