From Our 2007 Archives

FDA OKs 1st Generic Versions of Coreg

14 Companies Get FDA Approval to Make Generic Carvedilol

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

Sept. 5, 2007 -- The FDA today approved the first generic versions of Coreg (carvedilol).

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 way."

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 Inc.

The generic drugs' labels may differ from Coreg's label because parts of the Coreg labeling are protected by patents or exclusivity.

SOURCE: News release, FDA.





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