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# FDA Accepts Otsuka NDA Resubmission for Tolvaptan
- URL: https://www.fdaweb.com/fda-accepts-otsuka-nda-resubmission-for-tolvaptan/
- Published: 2017-11-09T12:00:00.000Z
- Updated: 2026-09-14T23:00:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140102

FDA has accepted an Otsuka Pharmaceutical Co. NDA resubmission for tolvaptan and its expanded use in treating adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The agency rejected an earlier submission in 2013, requesting additional data to further evaluate the product’s safety and efficacy in patients with ADPKD. The drug is currently approved for treating hyponatremia. FDA set a user fee review target date of 4/24/2018.

Tolvaptan is a selective V2 receptor antagonist that blocks the vasopressin-mediated activation of the cyclic adenosine monophosphate pathway that leads to cell proliferation and fluid secretion, according to the company. It is believed to inhibit cyst formation, proliferation and growth.