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Vaccines, Blood & Biologics
Our STN: BL 125113/47
Attention: Ms. Patricia E. Bakke
10210 Genetic Center Drive
San Diego, CA 92121
Dear Ms. Bakke:
We have approved your request to supplement your biologics license application for 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) for labeling changes to the Intended Use and Performance Characteristics of the package insert to use the Ultrio Assay as a test that confirms HBV infection in specimens that have a repeat reactive result in a licensed donor screening test(s) for HBsAg.
Please submit all final printed labeling at the time of use and include implementation information on Form FDA 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.
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 or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes this change.
We will include information contained in the above-referenced supplement in your biologics license application file.
Hira L. Nakhasi, Ph.D.
Division of Emerging and
Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics
Evaluation and Research