Posted by Michael Wonder on 08 Jan 2026
Vanda Pharmaceuticals announces receipt of FDA decision letter on Hetlioz supplemental new drug application for jet lag disorder
8 January 2026 - Vanda Pharmaceuticals today announced that it has received a decision letter from the US FDA's Center for Drug Evaluation and Research (CDER) concluding that the supplemental new drug application for Hetlioz (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form.
This letter stems from CDER's agreed re-review of the jet lag application under the October 1 collaborative framework agreement.
