And its own co-advancement partner Astellas Pharma US generic drugs.
Additional trial to be conducted for KYNAPID under FDA special protocol agreement Cardiome Pharma Corp. and its own co-advancement partner Astellas Pharma US, Inc. announced today that Astellas will undertake an individual confirmatory additional Phase 3 medical trial of KYNAPID Injection for speedy transformation of atrial fibrillation to sinus rhythm generic drugs . The trial, to be called ACT 5, is likely to begin enrolling patients by the ultimate end of 2009, with completion anticipated in the initial half of 2011.The decision to conduct another trial was reached following extended discussions with the FDA to define the very best regulatory path forward for KYNAPID.
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