Product Approval Information - Licensing Action
April 2, 2008
Our STN: BL 125245/17
Roche Molecular Systems, Inc.
Attn: Ms. Lesley Farrington
4300 Hacienda Drive
Pleasanton, CA 94588-2722
Dear Ms. Farrington:
We have approved your request to supplement your biologics license application for West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) to expand your claim to include testing for West Nile Virus RNA in post mortem cadaveric (non-heart-beating) donors using an individual testing format.
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).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/Hira L. Nakhasi, Ph.D./
Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research