August 27, 2007 Approval Letter
Our STN: BL 125247/0
OMRIX Biopharmaceuticals, Ltd.
Attn: Robert L. Zeid, TLI Development
113 SE 5th St.
Oak Island, NC 28465
Dear Mr. Zeid:
We have approved your biologics license application for Thrombin, Topical (Human) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Thrombin, Topical (Human) under your existing Department of Health and Human Services U.S. License No. 1603. Thrombin, Topical (Human) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Thrombin, Topical (Human) may be used in conjunction with an Absorbable Gelatin Sponge, USP.
Under this license, you are approved to manufacture Thrombin, Topical (Human) prepared at your facility, MDA Blood Services, Sheba Hospital, Ramat-Gan, POB 88, Kiryat Ono 55000, ISRAEL, REGISTRATION NUMBER 3003183625. You may label your product with the proprietary name EVITHROM® and will market it in 2 ml, 5 ml, and 20 ml dose vials.
The dating period for EVITHROM® shall be 2 years from the date of manufacture when stored frozen at -18oC and 30 days at 2-8oC when stored unopened.
Please submit final container samples of the product and each kit component in final containers 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 Biologics Evaluation and Research (CBER).
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of EVITHROM®, or in the manufacturing facilities.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should 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, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, 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 all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit two 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, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2253.
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 had them approved.
--- signature ---
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research