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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
May 1, 1998
Our Reference Numbers: 87-0508 and 87-0509
Herwig Igel, Ph.D.
Osterreichisches Institut für Haemoderivate Ges.m.b.H.
Industriestrasse 67
A- 1220 Vienna
Austria
Dear Dr. Igel:
Enclosed please find Biologics License 2.55 issued in accordance with the provisions of Section 35 1 (a) of the Public Health Service Act, as amended by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-l 15). This license authorizes Osterreichisches Institut für Haemoderivate Ges.m.b.H. to manufacture and ship for sale, barter or exchange in interstate and foreign commerce Fibrin Sealant for which your company has demonstrated compliance with establishment and product standards. Fibrin Sealant is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetratin,0 trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical. Fibrin Sealant is also indicated as an adjunct for the closure of colostomies.
Under this license you are authorized to manufacture and ship for sale, barter, or exchange Fibrin Sealant in 0.5 mL, 1.0 mL, 2.0 mL, and 5.0 mL kits. The Sealer Protein Concentrate (Human) and Thrombin (Human) components will be manufactured, vapor-heated, formulated, and fieeze-dried at your facility in Vienna, Austria. The Fibrinolysis Inhibitor Solution (Bovine) and Calcium Chloride Solution will be formulated and filled at your facility in Vienna, Austria from components as specified in your license application. Fibrinolysis Inhibitor will be produced from bovine material sourced from counties certified free of bovine spongiform encephalopathy. Nonbiological kit components will be supplied by contract manufacturers as specified in your license application. Fibrin Sealant will be distributed by Baxter Healthcare Corporation and
Haemacure Corporation. Changes to the product, production process, location of production process, equipment, 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 the individual components of this product shall be as follows: i) for the Sealer Protein Concentrate (Human) and Thrombin (Human), 24 months from the date of manufacture when stored at 2-8°C; ii) for the Fibrinolysis Inhibitor Solution (Bovine), 36 months from the date of manufacture when stored at 2-8°C; and iii) for the Calcium Chloride Solution, 5 years from the date of manufacture when stored at or below 25°C. The date of manufacture shall be defined as the date of sterile filtration for the Sealer Protein Concentrate (Human), Thrombin (Human), and Fibrinolysis Inhibitor Solution (Bovine). The date of manufacture shall be defined as the date of terminal sterilization for the Calcium Chloride Solution. The dating period for the Fibrin Sealant kits shall not exceed that of any of the components included therein when stored at 2-8°C. Results of ongoing stability studies should be submitted throughout the dating period as they become available.
You are requested to submit samples of each future lot of this product together with protocols showing results of all applicable tests. No lots of product shall be distributed until notification of release is received from the Director, Center for Biologics Evaluation and Research (CBER).
All adverse experience reports should be submitted according to 21 CFR 600.80 to the Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville Pike, Rockville, Maryland 20852-1448. It is also requested that distribution reports be submitted according to 2 1 CFR 600.8 1.
Please submit three (3) copies of final printed labeling at the time of use accompanied by Part II of FDA 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 2567 to CBER, Advertising and Promotional Labeling Staff (APLS), HFM-202, 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 2567 to APLS. Please include copies of the approved labeling with your proposed or final copy of advertising and promotional materials submitted to CBER.
Please acknowledge receipt of the enclosed Biologics License to the Director, Division of Blood Applications, HFM -370, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, Maryland 20852-1448.
Sincerely yours,
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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 |
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