Vanda Sues FDA Over Suspended Drug Study for Stomach Disorder

Vanda Pharmaceuticals Inc. is challenging an FDA decision that prevents the company from studying whether its motion sickness drug Nereus can be expanded to a treat a chronic stomach disorder.

The complaint filed Monday in the US District Court for the District of Columbia alleges the agency unlawfully issued a “partial clinical hold” that prevents it from studying Nereus’ long-term safety in patients with gastroparesis.

A partial clinical hold from the FDA is an order delaying or suspending specific parts of a drug’s clinical investigation.

“FDA provided two reasons for imposing the partial clinical hold, neither of which makes any ...