Good News: First Generic Versions of Coreg is Approved

Implications:  Food and Drug Administration (FDA) has approved the first generic versions of Coreg (carvedilol).  It is good news for patients. Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack. Generic Coreg contains same active ingredients (Carvedilol) as brand-name drugs and work the same way.  Carvedilol tablets in four strengths (3.125 milligrams, 6.25 mg, 12.5 mg and 25 mg) are manufactured by about 15 generic drug companies. All 15 pharmaceutical companies got approval on September 5, 2007. 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. Total annual market sales for Carvedilol Tablets were $1.6 billion . Overall I think it is a cost effective and safe alternative to expensive brand name drug product for patients.

Analysis:

Food and Drug Administration (FDA) has approved the first generic versions of Coreg (carvedilol).  It is good news for patients. Carvedilol is indicated for the treatment of mild-to-severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor and digitalis. Carvedilol is also indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction, as well as in the management of essential hypertension, alone or in combination with other antihypertensive agents. Generic Coreg contains same active ingredients (Carvedilol) as brand-name drugs and work the same way. The generic Coreg offers cost effective alternatives to patents in choosing their prescription drugs.  The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Coreg(R) Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, respectively, of GlaxoSmithKline.  Carvedilol tablets are manufactured by about 15 generic drug companies. All 15 pharmaceutical companies got approval on September 5, 2007. The following company’s applications were approved today (9/5): Actavis Elizabeth LLC; Apotex Inc.; Aurobindo Pharma Limited; Caraco Pharmaceutical Laboratories Limited; Dr. Reddy’s 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. Total annual market sales for Carvedilol Tablets were $1.6 billion and ranked30th top selling brand name drug by retail dollars in 2006. Overall I think it is a cost effective and safe alternative to expensive brand name drug product for patients.