Carvedilol and the Food and Drug Administration approval process: an introduction.

We discuss briefly the new drug carvedilol (Coreg), a beta-blocker, alpha-blocker, and antioxidant. This drug was developed for congestive heart failure 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 the classical paradigm of the U.S. Food and Drug Administration (FDA) for drug approval and the FDA's use of advisory committees. This document serves as background to the discussion of carvedilol's approval.