FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

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Summary

FDA is reviewing a supplemental application for LESCOL XL (fluvastatin sodium) from Sandoz Inc., likely involving changes to the product labeling.

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Diseases / indications

• Atherosclerotic Cardiovascular Disease
• Familial Hypercholesterolemia
• Hyperlipidemia

Drugs mentioned

• LESCOL XL (Fluvastatin sodium)

Snippet

SUPPL AP for LESCOL XL (FLUVASTATIN SODIUM)