Abbott's SIMCOR ® ( niacin extended-release / simvastatin ) Receives FDA Approval for New Dosage Strengths
ABBOTT PARK, Ill., July 28 Abbott (NYSE: ABT) today received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin - the most commonly prescribed dose of simvastatin - with either 500 mg or 1,000 mg of niacin extended-release. SIMCOR is the first treatment to combine Abbott's proprietary niacin extended-release and simvastatin, the most commonly used statin.
SIMCOR is a prescription medication used along with diet in people who cannot control their cholesterol levels by diet and exercise alone. SIMCOR is approved to raise HDL "good " cholesterol and lower levels of elevated total cholesterol, LDL " bad" cholesterol and triglycerides. SIMCOR is a combination medicine 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 simvastatin alone and niacin alone has been demonstrated.
"Approval of the new SIMCOR dosage strengths means that physicians and patients now have more options to treat complex lipid disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.
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 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 2010.
Treatment guidelines endorsed by the National Cholesterol Education Program, the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for some patients, as well as more aggressive management of HDL and triglycerides.
Important Safety Information About SIMCOR
SIMCOR should not be used by people with liver problems, stomach ulcers, or serious bleeding problems; in women who are pregnant, may become pregnant, or nursing. Unexplained muscle pain, tenderness, or weakness may be a sign of a serious but rare muscle disorder, from which rare cases of death have occurred. This risk of these muscle side effects is increased when SIMCOR is taken with certain types of medicines. SIMCOR is associated with increases in liver enzymes as measured by blood tests. Blood tests should be performed before and during treatment with SIMCOR to check for liver problems. SIMCOR should be used with caution by patients who consume large amounts of alcohol. SIMCOR may cause an increase in blood sugar levels which should be monitored closely in patients with diabetes.
Flushing (warmth, redness, itching, and/or tingling of the skin) is a common side effect that may subside after several weeks of consistent use. Other common side effects include headache, itching, nausea, back pain, and diarrhea.
More information about SIMCOR, including full prescribing information, is available on the Web site http://www.rxabbott.com/pdf/simcor_pi.pdf, or by calling Abbott Medical Information at 1-800-633-9110.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.
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