Vanda reaches FDA framework to resolve disputes on HETLIOZ and tradipitant

Vanda Pharmaceuticals Inc.

FDA expedited re-review of tradipitant clinical hold by Nov 26, 2025; PDUFA date Dec 30, 2025.
FDA expedited re-review of HETLIOZ sNDA for jet lag by Jan 7, 2026; Part 12 proceedings paused.
Vanda dismisses two lawsuits: one on tradipitant clinical hold (M.D. Fla.) and one on HETLIOZ info (S.D. Tex.).
Both parties seek temporary pause of tradipitant gastroparesis administrative proceedings until Jan 7, 2026.

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