Yamanouchi Vaprisol “approvable”
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Yamanouchi's Vaprisol (conivaptan) is "approvable" Nov. 30; FDA is requesting additional safety data for the hyponatremia agent. Discussions with the agency are ongoing but the company has not specified a timeframe for complete response. A September review by FDA's Endocrinologic & Metabolic Drugs Advisory Committee was cancelled. Vaprisol qualified for a priority review, but Yamanouchi opted for a standard review to allow time for the advisory committee to take place (1Pharmaceutical Approvals Monthly Nov. 1, 2004, p. 3)...