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Vaccines, Blood & Biologics

March 21, 2003 Approval Letter - Evicel

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

March 21, 2003

Our STN Number: BL 125010/0

Mr. Robert Taub
OMRIX biopharmaceuticals, Ltd.
200 Chaussee De Waterloo
1640 Rhode-St-Genese

Dear Mr. Taub:

This letter hereby issues Department of Health and Human Services U.S. License No. 1603 to OMRIX biopharmaceuticals, Ltd., Ramat Gan, Israel, in accordance with the provisions of Section 351 (a) of the Public Health Service Act controlling the manufacture and sale of biological products. This license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.

Under this license you are authorized to introduce or deliver for introduction into interstate commerce Fibrin Sealant (Human), Crossealä as sterile solutions in three dosage forms: 1 mL, 2 mL, or 5 mL. Fibrinogen potency in the Biological Active Component (BAC) is expressed as mg of clottable protein (specification 40-60 mg/ml) and as percent clottable protein --------------------------. Thrombin potency (specification 800-1200 IU/ml) is expressed in International Units (IU) by comparison to the World Health Organization (WHO) standard. The product is administered topically as an adjunct to hemostasis during liver surgery. Under this authorization, you are approved to manufacture Fibrin Sealant (Human), Crossealä at your manufacturing facility located at MDA Blood Bank, Tel Hashomer Hospital, Ramat Gan, 52621, Israel. Changes to the product, production process, location of production process, equipment, labeling, facilities, or responsible personnel are required to be reported to FDA as specified in Title 21 Code of Federal Regulations (CFR) Section 601.12.

The dating period for this product shall be 24 months from the date of manufacture when stored at <-18 oC with an allowance for storage at 2-8 oC for up to 30 days within the dating period. The date of manufacture for each component of Fibrin Sealant (Human), Crossealä shall be defined as the date of sterile filtration for each formulated bulk. Results of ongoing stability studies throughout the dating period will be submitted in annual reports.

We request you to submit final container samples of each kit component 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 Biologic Evaluation and Research (CBER).

You must submit adverse experience reports under the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and you must submit distribution reports under 21 CFR 600.81. You must submit postmarketing adverse experience reports and distribution reports to the FDA/CBER, HFM-210, 1401 Rockville Pike, Rockville, MD 20852-1448. Prominently identify all adverse experience reports as described in 21 CFR 600.80.

You must submit reports of biological product deviations under 21 CFR 600.14. You must promptly 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 and meets the other criteria in 21 CFR 600.14, 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 three (3) copies of final printed labeling at the time of use accompanied by Part II of FDA Form 2567 with completed implementation information. In addition, you may wish to submit your proposed introductory advertising and promotional campaign. If so, please submit three (3) copies of the proposed material in draft form with Part I of the FDA Form 2253 to FDA/CBER, Advertising and Promotional Labeling Branch (APLB), HFM-602, 1401 Rockville Pike, Rockville, Maryland 20852-1448. Promotional claims should be consistent with and not contrary to the 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. Final copies of advertising and promotional materials should be submitted at the time of use with Part II of FDA Form 2253 to APLB. Please include copies of the approved labeling with your proposed or final copy of advertising and promotional materials submitted to CBER.

Sincerely yours,

--- signature ---

Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research

--- signature ---

Steven A. Masiello
Office of Compliance and Biologics Quality
Center for Biologics Evaluation

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