The U.S. Food and Drug Administra tion (FDA) has approved the first generic versions of GlaxoSmithKline’s carvedilol drags (Coreg). This drug is approved to treat high blood pressure, mild to severe chronic heart failure, and left ventricular dysfunction following a heart attack.
Multiple generic drug companies manufacture carvedilol tablets in four strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg. Applications were approved for Actavis Elizabeth LLC, Apotex, Auro bindo, Caraco, Dr. Reddy’s, Glenmark, Lupin, Mylan, Ranbaxy, Sandoz, Taro, Teva, Watson, and Zydus.
The labeling of the generic products may differ from that of generic carvedilol be cause parts of the agent’s labeling are protected by patents and/or exclusivity.
Source: FDA, September 5, 2007
