FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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Summary

FDA approved a supplemental application for simvastatin by Lupin Pharmaceuticals, likely involving labeling changes. This represents a supplemental approval.

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Diseases / indications

• Atherosclerotic Cardiovascular Disease
• Hypercholesterolemia
• Hyperlipidemia

Drugs mentioned

• SIMVASTATIN (SIMVASTATIN)

Snippet

SUPPL AP for SIMVASTATIN (SIMVASTATIN)