Vanda Pharma Receives Decision Letter From FDA's CDER Concluding That sNDA For HETLIOZ For Treatment Of Jet Lag Disorder Cannot Be Approved In Its Current Form

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that it has received a decision letter from the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) 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.