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August 15, 1997 Approval Letter - Abbott HTLV-1/HTLV-II EIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

August 15, 1997

Our Reference Numbers: 95-0120/0121 and 95-0130

Mr. Matthew Klamrzynski
Abbott Laboratories
D49C, AP6C/2
Abbott Park, Buckley Road
    and Waukegan Road
North Chicago, IL 60064

Dear Mr. Klamrzynski:

Enclosed is a product license which authorizes Abbott Laboratories, U. S. License No. 43, to manufacture and sell in interstate and foreign commerce Human T-Lymphotropic Virus Types I and II. The product is to be used in an in vitro qualitative enzyme immunoassay (i.e., Abbott HTLV-I/HTLV-II EIA) for the detection of antibodies to human T-lymphotropic virus types I and II in human serum or plasma as described in your product license application, Reference Nos. 95-0120/0121.

You are requested to submit samples of each future master lot of the product with protocols consisting of a summary of essential manufacturing data inclusive of all applicable test results. No master lots of the product shall be distributed until notification of release is received from the Director, Center for Biologics Evaluation and Research (CBER).

Any lot of Human T-Lymphotropic Virus Types I and II found to fall outside of the approved specifications, including expiration dating periods, should be withdrawn from the market. In addition, any reports of significant product defects or product complaints concerning the use of the Abbott HTLV-I/HTLV-II EIA should be submitted to the Office of Compliance, CBER, HFM-650.

The expiration dating for the Abbott HTLV-IHTLV-II EIA is 15 months when stored at 2-8°C. Any request to extend this dating period must be accompanied by the results of ongoing stability studies.

In addition, your request to supplement your establishment license application to include areas for the manufacture of Human T-Lymphotropic Virus Types I and II, Reference No. 95-0130, has been approved. The information contained in this supplement will be included in your establishment license application file.

If you wish to prepare the licensed product or any of the ancillary components of the test kit other than as specified in your approved license applications, it may be necessary for you to submit a supplement to either your product or establishment license application for review and approval prior to implementation. If you wish to change any labeling, it will be necessary for you to submit a Transmittal of Labels and Circulars (Part I), Form FDA-2567, for review and approval before implementation.

A copy of your labeling submission is enclosed. Please submit three (3) copies of final printed labeling at the time of use and include Part II of the Transmittal of Labels and Circulars form (Form FDA-2567) with completed implementation information.

In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with a Form FDA-2567 to CBER, Advertising and Promotional Labeling Staff, HFM-202, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination accompanied by a Form FDA-2567. Promotional claims should be consistent with and not contrary to approved labeling. No comparative claims or claims of superiority over other similar products should be made unless data to support such claims are submitted to and approved by CBER.

Please acknowledge receipt of the enclosed product license by writing to the Director, Division of Blood Applications (HFM-370), Food and Drug Administration, CBER, c/o Document Control Center (HFM-99), Woodmont Office Center, Suite 200N, 1401 Rockville Pike, Rockville, Maryland 20852-1448.

Sincerely yours,

    --- signature ---    --- signature ---
Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Jerome A. Donlon, M.D., Ph.D.
Director
Office of Establishment Licensing and Product Surveillance
Center for Biologics Evaluation and Research