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FDA Accepts Otsuka Pharmaceutical Co., Ltd. Tolvaptan NDA for Priority Review


4/15/2013 8:49:26 AM

The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug candidate tolvaptan, a selective V2 vasopressin receptor antagonist. Otsuka Pharmaceutical president and representative director Dr. Taro Iwamoto said the NDA submission represents an important milestone for Otsuka and for patients with ADPKD. "Tolvaptan was discovered by Otsuka in Japan, and, if approved by the FDA, would become the first pharmaceutical therapy for patients who suffer from ADPKD," Iwamoto added.


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