Our STN: BL 125318/0
Attention: Ms. Susan Sanborn
Diagnostics Division, D-49C/AP6C-2
100 Abbott Park Road
Abbott Park, IL 60064-6092
Dear Ms. Sanborn:
We have approved your biologics license application (BLA) for Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide under your existing Department of Health and Human Services U.S. License No. 43. Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide is indicated for the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens.
Under this authorization, you are approved to manufacture Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide at your facility, 100 Abbott Park Road, Abbott Park, Illinois 60064, REGISTRATION NUMBER 1415939. You may label your product with the proprietary name ABBOTT PRISM HIV O Plus, that we have approved, and market it as approved.
We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefitted from an advisory committee discussion.
The dating period for Abbott PRISM HIV O Plus shall be 18 months from the date of manufacture when stored at the appropriate temperature required for each kit component. The expiration date for the packaged product, Abbott PRISM HIV O Plus, shall be dependent on the shortest expiration date of any component.
Please submit final container samples of the product Abbott PRISM HIV O Plus and each kit component in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).
You must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide, or in the manufacturing facilities.
You must submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80(k)(2). Since your product is characterized as a device as well as a biologic, 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, Maryland 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 content of labeling in Structured Product Labeling format. 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, Maryland 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 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