Incomplete Press Release Draws Untitled Letter

摘要

ZymoGenetics omitted certain information regarding a claim it made for topical hemostat Re-cothrom in a press release announcing FDA approval of the product, earning it an untitled letter. The FDA approved Recothrom (thrombin) in January as the first recombinant, plasma-free thrombin for use as a topical hemostat. In ZymoGenetics' press release announcing the approval, the company says, "A Phase 3 pivotal clinical trial showed that Recothrom had comparable efficacy and a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product."