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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review - ARTISS

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

Date: March 3, 2008
To: Administrative File: Submission Tracking Number (STN) -
BL 125266 Fibrin Sealant (FS VH S/D 4 or Tradename ARTISS)
Baxter Healthcare Corporation
Lic. # 0140, BLA
From: David Doleski, CBER/OCBQ/DMPQ/MRB2
Through: Chiang Syin, Ph.D., Chief, Branch 2, CBER/OCBQ/DMPQ
Subject: Review: Recommend Approval. This is a review of Baxter's BLA for Fibrin Sealant (FS VH S/D 4 or Tradename ARTISS) manufactured in ----------------

Action Recommended

Based on the information provided by Baxter in the submission, I recommend approval of the submission.

Review Comments

This BLA is an electronic submission in eCTD format.

This product is a Fibrin Sealant, although Baxter uses a code name of FS VH S/D 4, or the trade name of ARTISS.

The BLA for this product (ARTISS) is similar to TISSEEL Fibrin Sealant (BL 103980/5121), except for a difference in thrombin concentration (4 IU/ml vs. 500 IU/ml). Baxter claims that the manufacturing process for ARTISS ------------- -----------.

As with TISSEEL, ARTISS will be manufactured in three package sizes (2 mL, 4 mL and 10 mL, total volume) either as a lyophilized preparation with diluents or as a frozen liquid pre-filled into dual-chambered syringes. This BLA contains data supporting all sizes of the lyophilized form and the 10 mL size of the frozen form.



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Product Description:

Aprotinin Solution is one of the four components of the Fibrin Sealant VH S/D 4 Kit. The Fibrin Sealant VH S/D 4 Kit consists of 2 vials containing powder preparations of Sealer Protein Concentrate (Human) and Thrombin (Human) and two vials containing liquid preparations of Aprotinin and Calcium Chloride.

The Sealer Protein Concentrate (Human) is to be reconstituted with the Aprotinin and produces a solution that is referred to as the Sealer Protein Solution. The Thrombin (Human) is to be reconstituted with the Calcium Chloride, which produces a solution that is referred to as the Thrombin Solution.

Aprotinin is an excipient and acts as a fibrinolysis inhibitor. The 1 ml, 2 ml or 5 ml Aprotinin Solution vials are used for reconstitution of corresponding lyophilized Sealer Protein Concentrate sizes.

Conformance Lots: