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FDA approval · 2026-02-13

FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)

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Summary

FDA approved a supplemental application for Wakix (pitolisant hydrochloride) from Harmony Biosciences, LLC. The action typically updates labeling or adds indica…

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Diseases / indications

Drugs mentioned

  • WAKIX (pitolisant hydrochloride)

Snippet

SUPPL AP for WAKIX (PITOLISANT HYDROCHLORIDE)