ZymoGenetics Moves Ahead with Spray rhThrombin
Zymogenetics received good news recently when they released information that the FDA would NOT require more clinic studies for a spray to be used during surgery to stop bleeding.
ZymoGenetics spray moves ahead
This could shorten the timeline to approval for a spray by as much as 18 months but there would still need to be paperwork filled in the form of a Prior Approval Supplement. They filed for approval of rhThrombin in Dec 2006 and the spray would be a new formulation.
It should be noted that this would be the first Thrombin product which does not rely on animal or human blood. The currently approved thrombin products are derived cow blood and have potential problems such as concerns over Bovine Spongiform Encephalopathy (BSE) as well as leading to complications in some people who develop antibodies to the cow derived product.
Technorati Tags: Thrombin, Zymogenetics
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