FDA Approved: MYSOLINE — Supplemental Application (Bausch Health US, LLC)

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Summary

FDA approves a supplemental application for Mysoline (primidone) submitted by Bausch Health US, LLC. The action approves changes to the product labeling.

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Diseases / indications

• Epilepsy

Drugs mentioned

• MYSOLINE (PRIMIDONE)

Snippet

SUPPL AP for MYSOLINE (PRIMIDONE)