'Perplexed' Vanda falls back after jet lag drug setback

Shares in Vanda Pharmaceuticals (Nasdaq: VNDA) dropped in pre-market trading on Monday after the US company’s development of a jet lag disorder (JLD) drug suffered a major blow.

The US Food and Drug Administration (FDA) issued a complete response letter (CRL) as part of its review of Vanda’s supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon), a drug with an existing approval for sleep-wake disorder.

In July, the FDA notified Vanda that it had identified deficiencies in the sNDA that preclude discussion of labeling and postmarketing requirements.