Vanda Pharmaceuticals provides updates on tradipitant for motion sickness, including a brief extension for the re-review of the partial clinical hold and formal discussions on labeling for the New Drug Application.
FDA requests extension to December 5, 2025, for re-review of partial clinical hold.
PDUFA target action date for tradipitant remains December 30, 2025.
Partial Clinical Hold Re-Review
FDA requested an extension to December 5, 2025, for the re-review of the partial clinical hold on long-term studies of tradipitant.
Labeling Discussions Commenced
Formal discussions have begun between FDA and Vanda regarding the labeling for the New Drug Application of tradipitant for motion sickness.
PDUFA Target Action Date
The PDUFA target action date for tradipitant remains unchanged on December 30, 2025.
- Vanda's collaboration with the FDA showcases a commitment to addressing regulatory requirements promptly for tradipitant.
- Formal labeling discussions indicate progress towards potential commercialization of the first new pharmacologic treatment for motion sickness in over four decades.
Vanda Pharmaceuticals is actively engaging with regulatory agencies to advance the development and potential commercialization of tradipitant, offering hope for innovative treatments in motion sickness.