FDA clears Abbott's Simcor for two new dosage strengths
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.
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.