Jet lag drug hopes hit snag

Vanda Pharmaceuticals (Nasdaq: VNDA) has hit turbulence in its efforts to broaden the label of its sleep-wake disorder drug Hetlioz (tasimelteon).

The USA-based company is attempting to add the indication of jet lag disorder for Hetlioz, which was launched in the USA in 2014 for non-24-hour sleep wake disorder.

The US Food and Drug Administration (FDA) has notified Vanda that, as part of its ongoing review of the company’s supplemental New Drug Application (sNDA), the agency has identified deficiencies that preclude discussion of labeling and postmarketing requirements at this time.