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FDA approves 14 generic copies of GSK's Coreg

The FDA allows 14 generic manufacturers to sell first generic versions of GlaxoSmithKline's blood pressure drug Coreg in the US

The FDA has given 14 generic manufacturers permission to sell the first generic versions of GlaxoSmithKline's (GSK) blood pressure drug Coreg (carvedilol) on the US market.

The agency stated on 5 September 2007 that the companies, which included Caraco Pharmaceutical, Mylan, Ranbaxy and Watson, could sell generic versions of Coreg in strengths of 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.

Coregis is approved in the US to treat high blood pressure, mild-to-severe chronic heart failure and left ventricular dysfunction following a heart attack.

GSK sells a newer, daily reformulation of the drug called Coreg CR, which is patent protected until 2023, according to the UK-based firm.

30th September 2008

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