Abbott submits SIMCOR sNDA for two new dosage strengths

Dec 10 2009

Abbott (NYSE: ABT) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin.

Abbott is seeking FDA approval for the following new dosage strengths of SIMCOR: 500/40 mg and 1000/40 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 1000/20 mg. The original FDA approval was supported by results from the SEACOAST trial, which demonstrated efficacy and safety of SIMCOR up to doses of 2000/40 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.

"If approved, availability of new SIMCOR dosage strengths would be good news for the many patients with complex lipid disease who need additional options to treat their HDL, LDL and triglycerides," said Eugene Sun, M.D., vice president, Global Clinical Development, Abbott.