Vanda Pharmaceuticals Inc.
CRL Confirmed
HETLIOZ
jet lag disorder
Resolved
181days ago
FDA decision Β· Jan 7, 2026
What's at stake An FDA complete response letter on HETLIOZ for jet lag disorder is in focus around Jan 7, 2026.
β€œOn January 7, 2026, Vanda received a letter from the FDA stating that, following this re-review, it had concluded that the sNDA cannot be approved in its current form.”

Provenance

2 sources on file.

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