Shionogi Gets Untitled Letter for Refusing To Conduct Study

The FDA issued Shionogi an untitled letter for refusing to conduct a postmarketing study required as part of an NDA approval. Shionogi declined to conduct two clinical trials for Rybix ODT that might identify an unexpected serious risk of QT prolongation/torsade de pointes associated with the use of the pain drug tramadol. The agency asked for the studies in 2012.
Washington Drug Letter