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SMITHKLINE FILES CORLOPAM (FENOLDOPAM) NDA

Executive Summary

SMITHKLINE FILES CORLOPAM (FENOLDOPAM) NDA on Dec. 12: the company is initially seeking approval of an I.V. formulation of the inotropic agent for use in treating severe hypertension. An oral formulation of fenoldopam is also in development for treatment of congestive heart failure and mild to moderate hypertension. The NDA filing is a seasonal bright note for Smith Kline & French R&D, which has experienced a number of recent disappointments. Following the departure of R&D head Stanley Crooke last summer, SmithKline consolidated the three pieces of its prescription drug business - U.S., international and R&D - under one exec, John Chappell. The company recently returned rights to a potential "son of Tagamet" H2 receptor antagonist as well as a congestive heart failure drug, ibopamine, to Bristol-Myers and Zambon, respectively. Both compounds were in the late stages of clinical development. Fenoldopam, a selective dopamine agonist, is one of a number of cardiovascular products working their way through the SmithKline pipeline. Carvedilol, a vasodilating beta blocker licensed from Boehringer Mannheim, is also nearing the NDA filing stage. Further back, two thromboxane receptor antagonists are in clinical trials.
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