tolvaptan

FDA Drug Profile — SAMSCA, tolvaptan, Jynarque, JYNARQUE

Drug Details

Generic Name
tolvaptan
Brand Names
SAMSCA, tolvaptan, Jynarque, JYNARQUE
Application Number
NDA022275
Sponsor
Otsuka America Pharmaceutical, Inc.
NDC Codes
11
Dosage Forms
TABLET, KIT
Routes
ORAL
Active Ingredients
TOLVAPTAN

Indications and Usage

1 INDICATIONS AND USAGE JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). JYNARQUE is a selective vasopressin V 2 -receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) ( 1 )