Vanda Sues FDA for Hearing on Drug to Treat Jet Lag Disorder

The US Food and Drug Administration has unlawfully failed to give Vanda Pharmaceuticals Inc. a hearing to determine if it can add jet lag disorder to the label for an already-approved drug, a complaint filed in the US District Court for the District of Columbia says.

The Federal Food, Drug and Cosmetic Act and its implementing regulations require the agency to publish in the Federal Register a notice of an opportunity for a hearing on a supplemental new drug application within 180 days of the application’s filing, Vanda says in the complaint. The law also requires publication of the same ...