December, 14, 2009 – A supplemental new drug application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR, a cholesterol medication.
Abbott’s SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin. The company is seeking FDA approval for the following new dosage strengths of SIMCOR: 500/40 mg and 1,000/40 mg (niacin extended-release/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. The original FDA approval was supported by results from the SEACOAST trial, which demonstrated efficacy and safety of SIMCOR up to doses of 2,000/40 mg daily in patients with mixed dyslipidemia and type II hyperlipidemia.
SIMCOR is a prescription medicine used along with diet in people who cannot control their cholesterol levels by diet and exercise alone. SIMCOR is approved to lower levels of elevated total cholesterol, LDL “bad” cholesterol and triglycerides, and to raise HDL “good” cholesterol. SIMCOR is used when treatment with simvastatin alone or niacin extended-release alone is not considered adequate. No additional benefit of SIMCOR on heart disease over and above that shown for niacin alone and simvastatin alone has been demonstrated.
The company said the new dosage strengths would help many patients with complex lipid disease who need additional options to treat their HDL, LDL and triglycerides.
For more information: www.rxabbott.com, www.abbott.com