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Abbott submits FDA application for SIMCOR

Posted on 11/12/2009 in Pharmaceutical Company Product News

Abbott has announced the submission of an application with the Food and Drug Administration (FDA) for the approval of SIMCOR (niacin extended-release/simvastatin).

The company is seeking FDA approval for new 500/40 mg and 1000/40 mg doses of the drug - which is a prescription medicine used along with diet in people who cannot control their cholesterol levels through diet and exercise.

SIMCOR was approved by the FDA in February 2008 in doses of 500/20 mg, 750/20 mg and 1000/20 mg, but futher trials have demonstrated the efficacy of higher doses.

"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, vice-president of global clinical development at Abbott.

Meanwhile, Abbott's technology Ibis was last week named by Science magazine as one of the most innovative products of 2009.

Other news stories from 11/12/2009

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