Neurex Corlopam (fenoldopam I.V.) "approvable" letter expected at start of fourth quarter, company says.

Executive Summary

NEUREX CORLOPAM "APPROVABLE" LETTER EXPECTED AT START OF FOURTH QUARTER, the company said July 29. The company submitted its NDA for fenoldopam I.V. in June 1996; the extended user fee deadline is in early October, Neurex indicated. FDA's Cardiovascular & Renal Drugs Advisory Committee recommended at its June 26 meeting that the product be approved for the treatment of hypertension when oral therapy is not practical and for severe hypertension ("The Pink Sheet" June 30, T&G-2). The advisory committee said it would like to see additional data on fenoldopam's interaction with beta blockers, but split a vote over whether the information should be provided prior to or after approval.