Abbott has submitted a supplemental new drug application (sNDA) to the U.S. Food andDrug Administration (FDA) for two new dosage strengths of SIMCOR, acholesterol medication. SIMCOR is a fixed-dose combination of niacinextended-release and simvastatin. Abbott is seeking FDA approval for the following new dosage strengths ofSIMCOR: 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 supportedby results from the SEACOAST trial, which demonstrated efficacy and safety ofSIMCOR up to doses of 2000/40 mg daily in patients with mixed dyslipidemia andtype II hyperlipidemia. SIMCOR is a prescription medicine used along with diet in people whocannot control their cholesterol levels by diet and exercise alone. SIMCOR isapproved to lower levels of elevated total cholesterol, LDL “bad” cholesteroland triglycerides, and to raise HDL “good” cholesterol. SIMCOR is used whentreatment with simvastatin alone or niacin extended-release alone is notconsidered adequate. No additional benefit of SIMCOR on heart disease overand above that shown for niacin alone and simvastatin alone has beendemonstrated. “If approved, availability of new SIMCOR dosage strengths would be goodnews for the many patients with complex lipid disease who need additionaloptions to treat their HDL, LDL and triglycerides,” said Eugene Sun, M.D.,vice president, Global Clinical Development, Abbott.
