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news.ZymoGenetics has announced that the FDA has approved a prior approval supplement application for a 20,000 international unit vial of Recothrom Thrombin, topical and also approved co-packaging of the 20,000-IU vial with the ZymoGenetics Spray Applicator Kit.
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Recothrom 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.
Bruce Carter, CEO of ZymoGenetics, said: “Recothrom, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes. Within two weeks, we’ll be ready to ship the 20,000-IU vials, as well as spray kits co-packaged with the larger vial. This product introduction will provide our customers with flexibility to meet their needs while enhancing our ability to convert hospital thrombin usage to Recothrom.”