Product Approval Information - Licensing Action
January 2, 2008
Our STN: BL 125010/105
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) for a new indication, use in general surgery.
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 note that you have fulfilled 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 and FDA Form 2567. Please provide a PDF-format electronic copy as well as original paper copies (five for circulars and five for other labels).
Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination with a FDA Form 2253, to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have submitted data to support such claims to us and received CBER approval for such claims.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/Basil Golding, M.D./
Basil Golding, M.D.
Director, Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research