Extended-release Horizant fails to gain FDA approval

02/17/2010 | Reuters

The FDA issued a complete-response letter for extended-release Horizant, a treatment for moderate to severe restless legs syndrome from XenoPort and GlaxoSmithKline. The drugmakers said they will communicate with the FDA on the future of the drug, which was linked to pancreatic acinar cell tumors in rats during preclinical studies.

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