FDA Approved: SIMVASTATIN — Original Application (Micro Labs Limited)

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Summary

FDA approves Micro Labs Limited's original ANDA for simvastatin, a generic statin, enabling broader generic access in the U.S.

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Diseases / indications

• Atherosclerotic Cardiovascular Disease
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipidemia

Drugs mentioned

• SIMVASTATIN (SIMVASTATIN)

Snippet

ORIG AP for SIMVASTATIN (SIMVASTATIN)