DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
October 13, 2005
Our STN: BL 103785 / 0
Attention: Matt Klamrzynski
Director, ADD Regulatory Affairs
100 Abbott Park Road
Chicago, IL 60064
Dear Mr. Klamrzynski:
We have approved your biologics license application for Hepatitis B Virus Core Antigen (E.coli, Recombinant) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Hepatitis B Virus Core Antigen (E.coli, Recombinant) under your existing Department of Health and Human Services U.S. License No. 0043. Hepatitis B Virus Core Antigen (E.coli, Recombinant) [ABBOTT PRISM HBcore] is indicated for the qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma. The ABBOTT PRISM HBcore is intended to be used as a screening test for blood and plasma to prevent transmission of hepatitis B virus (HBV) to recipients of blood and blood components.
Under this license, you are approved to manufacture Hepatitis B Virus Core Antigen (E.coli, Recombinant) prepared at your facility, 100 Abbott Park Road, Chicago, IL 60064, REGISTRATION NUMBER 1415939. You must label your product with the proper name: Hepatitis B Virus Core Antigen (E.coli, Recombinant), [ABBOTT PRISM HBcore] that we have approved, and market it as approved in your license application.
The dating period for Hepatitis B Virus Core Antigen (E.coli, Recombinant) shall be 12 months from the date of manufacture when stored at 2-8oC. The expiration date for the packaged product, ABBOTT PRISM HBcore, shall be dependent on the shortest expiration date of any kit component.
Please submit final container samples of the product 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 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 Hepatitis B Virus Core Antigen (E.coli, Recombinant), or in the manufacturing facilities.
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.
--- signature ---
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research