Otsuka Oral Tolvaptan NDA Carries August Goal For FDA Action
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's acceptance of Otsuka's NDA for the investigational V2-vasopressin receptor antagonist tolvaptan positions the drug to be the first oral product in the increasingly crowded vasopressin antagonist market
You may also be interested in...
Astellas Vaprisol supplemental approval
Astellas' vasopressin antagonist Vaprisol (conivaptan) is approved for a second indication to treat patients with hypervolemic hyponatremia, the Japanese firm announces March 2. Vaprisol was initially approved Dec. 29, 2005 for use in euvolemic hyponatremia (1Pharmaceutical Approvals Monthly January 2006, p. 3). An "approvable" letter for the hypervolemic claim was issued simultaneously...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product