FDA OKs 1st Generic Versions of Coreg
14 Companies Get FDA Approval to Make Generic Carvedilol
Sept. 5, 2007 -- The FDA today approved the first generic versions of Coreg
Coreg is a widely used prescription drug that is FDA-approved to treat high
blood pressure, mild to severe chronic heart failure, and to improve the
function of the heart's left ventricle after a heart attack.
The FDA approved generic carvedilol tablets in four strengths: 3.125
milligrams, 6.25 milligrams, 12.5 milligrams, and 25 milligrams.
The FDA's Office of Generic Drugs "ensures that generic drugs are safe
and effective through a rigorous scientific and regulatory process," states
Gary Buehler, RPh, in an FDA news release.
Buehler, who directs the FDA's Office of Generic Drugs, says generic drugs
"use the same active ingredients as brand-name drugs and work the same
Generic carvedilol applications were approved for the following 14
companies: Actavis Elizabeth, 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
The generic drugs' labels may differ from Coreg's label because parts of the
Coreg labeling are protected by patents or exclusivity.