FDA rejects Vanda's HETLIOZ sNDA for jet lag disorder after expedited re-review

Vanda Pharmaceuticals Inc.

FDA concluded sNDA cannot be approved in current form, citing phase advance protocols not sufficiently analogous to actual jet travel.
FDA acknowledged positive efficacy from controlled trials but said data do not provide substantial evidence of effectiveness.
Vanda respectfully disagrees and will pursue all appropriate avenues for approval; notes prior D.C. Circuit ruling set aside FDA refusal.
Expedited re-review was completed by Jan 7, 2026 under collaborative framework agreement from October 2025.
HETLIOZ (tasimelteon) currently approved for non-24-hour sleep-wake disorder; jet lag would be new indication.

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