Vanda’s Jet Lag Drug Gets Fresh FDA Look After Court Ruling (1)

The FDA lacked justification to deny Vanda Pharmaceuticals Inc. an evidentiary hearing before rejecting the manufacturer’s application for its jet lag disorder drug, a federal appeals court panel ruled Friday.

The Food and Drug Administration’s refusal to hold a hearing before denying Vanda’s supplemental new drug application “was arbitrary and capricious,” and the case should be sent back to the FDA for future proceedings, Judge Bradley N. Garcia of the US Court of Appeals for the District of Columbia Circuit wrote in the opinion for the court.

The case centers on an application for Hetlioz, a Vanda drug the FDA ...