Carvedilol and the Food and Drug Administration approval process: An introduction

We discuss briefly the new drug carvedilol (Coreg(R)), a beta-blocker, alph a-blocker, and antioxidant. This drug was developed for congestive heart fa ilure in a series of trials, four in the United States and one in Australia and New Zealand, briefly summarized in this document. We also summarize th e classical paradigm of the U.S. Food and Drug Administration (FDA) for dru g approval and the FDA's use of advisory committees. This document serves a s background to the discussion of carvedilol's approval. (C) Elsevier Scien ce Inc. 1999.