Product Approval Information - Licensing Action
May 9, 2007
Our STN: BL 125010/74
Omrix biopharmaceuticals Ltd.
Attention: Mr. Robert L. Zeid/TLI Development
113 SE 5th Street
Oak Island, NC 28465
Dear Mr. Zeid:
We have approved your request to supplement your biologics license application for Fibrin Sealant (Human) to include as an indication, an adjunct to hemostasis for use in patients undergoing liver or vascular surgery when control of bleeding by standard surgical techniques is ineffective or impractical.
All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens must contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are waiving the pediatric study requirement for this application.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide both a Word and PDF-format electronic copy as well as five original paper copies. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
--- signature ---
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research