FDA Approved: SIMVASTATIN — Original Application (Accord Healthcare, Inc.)

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Summary

FDA approved Accord Healthcare's generic simvastatin as an original ANDA, enabling marketing of a generic statin for lipid-lowering indications.

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Diseases / indications

• Atherosclerotic Cardiovascular Disease
• Hypercholesterolemia
• Hyperlipidemia

Drugs mentioned

• SIMVASTATIN (SIMVASTATIN)

Snippet

ORIG AP for SIMVASTATIN (SIMVASTATIN)