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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
January 2, 2003
Our STN Number: BL 103764/5037
Nancy Del Viscio
Novartis Pharmaceutical Corporation
One Health Plaza
East Hanover, NJ 07936-1080
Dear Ms. Del Viscio:
Your request to supplement your biologics license application for Basiliximab to include the addition of a new single dose 10 mg strength of drug product and an additional supplier of -- mL glass vials for 10 mg and 20 mg strengths, --------------------------------------------------------------------, has been approved.
In addition, your request to provide for the following changes in release testing and specifications that are different from the 20 mg strength have been approved:
- Replacement of the -------------------------------- test for bacterial endotoxins with the ------------------------------------------------------------ assay as a release test for the drug product;
- Tightened release specifications in the --------------------------------------------------------------------------------------------------, and --------- assays for 10 mg vials of drug product;
- Change in standard solutions used to evaluate system suitability for the “assay by ---”, the “assay for byproducts and degradation products by ---”, and the “assay for byproducts and degradation products by ---”; and,
- · Change in ------------------------------------- of dose points per curve to include more than ---- points.
For the 20 mg strength, the above changes in release testing and specifications can be reported in your annual report (21 CFR 601.12(d)).
Please submit 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).
Results of ongoing stability studies should be submitted throughout the dating period, as they become available, including the results of stability studies from the first three production lots.
This information will be included in your biologics license application file.
Sincerely yours,
--- signature ---
Keith O. Webber, Ph.D.
Director
Division of Monoclonal Antibodies
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 1/24/2003
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Date created: September 25, 2003 |
