FDA extends parcial clinical hold re-review to Dec 5; PDUFA date remains Dec 30 for tradipitant

Vanda Pharmaceuticals Inc.

FDA and Vanda agreed to extend partial clinical hold re-review target to Dec 5, 2025 (from Nov 26) due to CDER personnel transitions.
PDUFA action date for tradipitant NDA for motion sickness vomiting prevention unchanged at December 30, 2025.
FDA issued labeling comments; labeling discussions with Vanda have formally commenced.
Vanda aims to deliver first new pharmacologic treatment for motion sickness in over 40 years.

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