DC Circuit Weighs FDA’s Fast-Track Denial For Vanda Stomach Drug

The FDA’s decision to reject expedited review of Vanda Pharmaceuticals Inc.’s gastroparesis drug tradipitant appeared reasonable to an appeals court Wednesday.

A three-judge panel of the US Court of Appeals for the District of Columbia Circuit seemed open to the Food and Drug Administration’s determination that Vanda didn’t provide the sufficient data and studies to show that its drug created to treat severe nausea in patients with gastroparesis deserved fast-track designation.

At issue before the judges is whether a lower court was right to uphold that the FDA didn’t act arbitrarily and capriciously under the Administrative Procedure Act when it ...