Product Approval Information

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

July 3, 1996

Our Reference Nos. 95-1190 and 95-1210

John H. Parker, Ph.D.
Centocor B.V.
Einsteinweg 101,
P.O. Box 251
2300 AG Leiden, The Netherlands

Dear Dr. Parker:

Your biologics license application for Imciromab pentetate is approved effective this date. Centocor, B.V., Leiden, The Netherlands, is hereby authorized to manufacture and import into this country for sale, barter, or exchange Imciromab pentetate under Department of Health and Human Services Biologics License No. 1178.

Imciromab pentetate is indicated for the preparation of Indium In 111 Imciromab pentetate to be used as a cardiac imaging agent for detecting the presence and/or identifying the location of myocardial injury in patients with suspected myocardial infarction.

In accordance with approved labeling, your product will bear the tradename Myoscint, and will be marketed as a single dose kit containing one 1 ML vial of Imciromab pentetate solution and one 1 ML vial of citrate-buffer solution.

You are not currently required to submit samples of future lots of Imciromab pentetate to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2. FDA will continue to monitor compliance with 21 CFR 610.1 requiring assay and release of only those lots that meet release specifications.

The dating period for this product shall be 18 months from the date of manufacture when stored at 2-8°C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated product. Results of ongoing stability studies should be submitted at throughout the dating period as they become available including the results of stability studies from the first three production lots.

We acknowledge your commitments of June 26, 1996, to complete all actions listed in your response to the FDA 483 observations and submit data and/or SOPs in support of those actions within six months of the date of this letter. We also acknowledge your commitment of July 2, 1996 to submit a galley proof of the package insert for review and approval prior to implementation.

Any changes in the manufacture, packaging or labeling of the product or in the manufacturing facilities will require the submission of information to your biologics license application for our review and written approval consistent with 21 CFR 601.12.

It is requested that adverse experience reports be submitted in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and that distribution reports be submitted as described (21 CFR 600.81). These requirements became effective on December 27, 1994. All adverse experience reports should be prominently identified according to 21 CFR 600.80 and be submitted to the Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit three copies of all final printed labeling at the time of use and include part II of the label transmittal form (FDA Form 2567) with completed implementation information. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 to the Center for Biologics Evaluation and Research, 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 an FDA Form 2567. All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other similar products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.

Sincerely yours,

Last Updated: 1/17/2001

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Date created: September 25, 2003

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