The U.S. Food and Drug Administration has approved the first generic versions of Coreg, or carvedilol.
Coreg is a widely used medication to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.
The agency's Office of Generic Drugs ensures that generic drugs are safe and effective through a rigorous scientific and regulatory process, said Gary J. Buehler, director, FDA's Office of Generic Drugs.
Generic drugs, which use the same active ingredients as brand-name drugs and work the same way, offer alternatives to Americans in choosing their prescription drugs.
Carvedilol tablets in four strengths - 3.125 milligrams, 6.25 milligrams, 12.5 milligrams and 25 milligrams - are manufactured by multiple generic drug companies. The following companys applications were approved: Actavis Elizabeth LLC; Apotex Inc.; Aurobindo Pharma Limited; Caraco Pharmaceutical Laboratories Limited; Dr. Reddys Laboratories; Glenmark Pharmaceuticals Limited; Lupin Limited; Mylan Pharmaceuticals Inc.; Ranbaxy Laboratories Ltd.; Sandoz Inc.; Taro Pharmaceutical Industries Ltd.; TEVA Pharmaceuticals USA; Watson Laboratories Inc.; and Zydus Pharmaceuticals USA Inc.
The labeling of the generic products may differ from that of Coreg because parts of the Coreg labeling are protected by patents and/or exclusivity.
According to the publication Drug Topics, Coreg was the 30th top selling brand name drug by retail dollars in 2006.
