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FDA approval · 2025-09-25

FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

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Summary

FDA approved Vertex's supplemental application for SYMDEKO (tezacaftor and ivacaftor). The approval updates the product labeling.

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Diseases / indications

Drugs mentioned

  • Symdeko (tezacaftor/ivacaftor)

Snippet

SUPPL AP for SYMDEKO (TEZACAFTOR AND IVACAFTOR)