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FDA Information

Carvediol (carvedilol) was granted final US FDA approval for mild-moderate heart failure in May 1997. An indication for use in severe heart failure received approval in November 2001 based on the COPERNICUS trial findings: carvediol reduced mortality and hospitalization rate in patients with severe chronic heart failure.

In March 2003, carvediol received approval for use in the prevention of cardiovascular mortality in stable patients with left ventricular dysfunction following acute myocardial infarction. It has also been studied in stable angina pectoris.

Carvediol (carvedilol) has been marketed in Europe since the 1980s under the trade name Kredex®.

Please visit the official site of the FDA for further information.

 

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