May 27, 2008 - ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that the United States Food and Drug Administration (FDA) has approved a Prior Approval Supplement application for a 20,000 international unit (IU) vial of RECOTHROM(TM) Thrombin, topical (Recombinant) and also approved co-packaging of the 20,000-IU vial with the ZymoGenetics Spray Applicator Kit.
"RECOTHROM, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes," said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. "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. Additionally, we believe that our spray kit has design and convenience advantages, based on market research conducted with surgeons."
The details can be read here.
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