FDA clears Abbott's Simcor for two new dosage strengths

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The FDA has approved two new dosage strengths of Abbott's Simcor, a cholesterol medication.

The new Simcor dosage strengths combine 40 mg of simvastatin with either 500 mg or 1,000 mg of niacin extended-release, according to the Abbott Park, Ill.-based company. Simcor is the first treatment to combine Abbott's niacin extended-release and simvastatin.

Simcor was approved by the FDA in February 2008 in the following strengths: 500/20 mg, 750/20 mg and 1,000/20 mg. Abbott said the original FDA approval was supported by results from the SEACOAST trial, which demonstrated efficacy and safety of Simcor up to doses of 2,000 mg niacin extended-release/40 mg simvastatin daily in patients with mixed dyslipidemia and type II hyperlipidemia.

The Simcor 40 mg strengths will be available in early August, according to the company.