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Vaccines, Blood & Biologics

January 28, 2011 Approval Letter - Procleix Ultrio Assay


Gen-Probe Incorporated
Attention: Ms. Patricia Bakke
10210 Genetic Center Drive
San Diego, CA  92121
Dear Ms. Bakke:
We have approved your request to supplement your biologics license applications to update the package inserts to remove content related to the “10% Invalid Rule” due to revisions of the assay software used to perform these assays on the PROCLEIX TIGRIS System. The following biologics license application supplements are included:
STN Name of Biological Products 
BL 125113/43
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and HCV and HBV/Nucleic Acid Pooled Testing/Synthetic)
BL 125121/47
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Please submit all final labeling as a Product Correspondence to these BLAs at the time of use (prior to marketing) and include implementation information on FDA Form 356h. Please provide a PDF electronic copy as well as three original paper copies for circulars and other labels.
Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.

We will include information contained in the above-referenced supplements in your biologics license application files.
Sincerely yours,
Hira L. Nakhasi, Ph.D.
Division of Emerging and
 Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research

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