October 4, 2006 Approval Letter
October 4, 2006
Our STN: BL 103966/5040
Attn: Leanne Kiviharju
10210 Genetic Center Drive
San Diego, California 92121
Dear Ms. Kiviharju:
We have approved your supplement to your biologics license application for Human Immunodeficiency Virus Type 1 and Hepatitis C Virus (HIV-1 and HCV/Nucleic Acid Pooled Testing/Synthetic), effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, APTIMA® HIV-1 RNA Qualitative Assay under your existing Department of Health and Human Services U.S. License No. 1592. APTIMA® HIV-1 RNA Qualitative Assay is indicated for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection.
Under this authorization, you are approved to manufacture APTIMA® HIV-1 RNA Qualitative Assay at your facilities in San Diego, California. You may label your product with the proprietary name APTIMA® HIV-1 RNA Qualitative Assay.
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of APTIMA® HIV-1 RNA Qualitative Assay, or in the manufacturing facilities.
Submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by (21 CFR 600.81(k)(2)). Since your product is characterized as a device as well as a biological, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, Maryland 20847-3002.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2253.
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 submitted data to support such claims to us and had them approved.
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research