FDA Grants Approval for Generic Versions of Coreg
Carvedilol widely used to treat myocardial infarction patients
THURSDAY, Sept. 6 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval to companies to manufacture the first generic versions of Coreg (carvedilol) for the treatment of high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction after myocardial infarction.
Approval was granted to 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 drug will be manufactured in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg doses. The exclusivity and patents that apply to Coreg may mean that generic versions carry different labeling.
"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, R.Ph., director of FDA's Office of Generic Drugs, in a statement. "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."