Vanda Pharmaceuticals receives FDA letter on HETLIOZ jet lag disorder sNDA.

Vanda Pharmaceuticals has received a decision letter from the FDA stating that the sNDA for HETLIOZ for jet lag disorder cannot be approved in its current form. The FDA acknowledged positive efficacy from Vanda's controlled clinical trials, but concluded that the data do not provide substantial evidence of effectiveness. The decision comes under a collaborative framework agreement between the FDA and Vanda.