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Home » FDA Reviewers Say No to Proposed New Indication for Otsuka’s Tolvaptan
FDA Reviewers Say No to Proposed New Indication for Otsuka’s Tolvaptan
August 1, 2013
In briefing documents released Thursday, FDA reviewers explicitly say they do not support approving Otsuka’s vasopressin receptor antagonist tolvaptan to treat autosomal dominant polycystic kidney disease (ADPKD), citing risks of liver injury in patients with the disease.