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Friday, November 10, 2017

Otsuka Pharmaceutical Co. Ltd., of Tokyo, said the FDA accepted the resubmission of its NDA for tolvaptan in the treatment of adults with autosomal dominant polycystic kidney disease. The resubmission, which was assigned a PDUFA action date of April 24, 2018, is a response to a complete response letter issued in August 2013.

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