Bristol Vanlev "approvable" requests additional study
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bristol-Myers Squibb expects to make a decision "in a month or so" as to whether and how to proceed with the Vanlev (omapatrilat) NDA following an Oct. 11 "approvable" letter. FDA is requesting an additional study in patients resistant to "multiple other antihypertensives used in combination at their highest tolerated doses." The letter is consistent with July 19 recommendations of the Cardiovascular & Renal Drugs Advisory Committe