Abbott Seeks FDA Approval Of New Dosage Strengths Of SIMCOR(R) (niacin Extended-release/simvastatin)

Main Category: Cholesterol
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 11 Dec 2009 - 4:00 PST

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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.

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, and should be reported to a health care provider right away. This risk is increased when SIMCOR is taken with certain types of medicines. Patients should tell their health care provider about all the medicines they take. 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. Women of childbearing age should use an effective method of birth control to prevent pregnancy while using SIMCOR. Flushing (warmth, redness, itching, and/or tingling of the skin) is a common side effect that may subside after several weeks of consistent use. Additional symptoms may include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or swelling. Flushing may vary in severity and is more likely to occur when starting therapy or during dose increases. Other common side effects include headache, itching, nausea, back pain, and diarrhea.

About Abbott

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 more than 72,000 people and markets its products in more than 130 countries.

Source: Abbott

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