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Vytorin Approval History

FDA Approved: Yes (First approved July 23, 2004)
Brand name: Vytorin
Generic name: ezetimibe/simvastatin
Dosage form: Tablets
Company: Merck/Schering-Plough Pharmaceuticals
Treatment for: High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous

Vytorin (ezetimibe/simvastatin) is a combination of ezetimibe (a lipid-lowering compound) and simvastatin (an HMG-CoA reductase inhibitor) for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

Development History and FDA Approval Process for Vytorin

DateArticle
Jan 25, 2012Approval New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
Jul 23, 2004Approval Vytorin Merck/Schering-Plough Pharmaceuticals - Treatment for Cholesterol Reduction

Further information

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