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Home » Shionogi Gets Untitled Letter for Refusing To Conduct Study
Shionogi Gets Untitled Letter for Refusing To Conduct Study
June 5, 2013
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
Washington Drug Letter
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