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ZymoGenetics submits petition against Thrombin-JMI

August 20, 2009 11:01 PM UTC

ZymoGenetics Inc. (NASDAQ:ZGEN) submitted a Citizen's Petition to FDA requesting the agency remove bovine-derived Thrombin-JMI thrombin from King Pharmaceuticals Inc. (NYSE:KG) from the market due to safety concerns. In its petition, ZymoGenetics said that antibodies formed in some patients in response to proteins contained in bovine thrombin preparations may interfere with the coagulation process and cause immune-mediated coagulopathy (IMC), a potentially fatal condition. ZymoGenetics said more than 25 cases of IMC in patients exposed to bovine thrombin preparations have been published since 2000. Thrombin-JMI's label already contains a boxed warning regarding the risk of IMC. King declined to comment. ...