DC Circuit Affirms FDA’s Fast-Track Denial of Vanda Stomach Drug

The FDA properly determined that Vanda Pharmaceuticals Inc.’s gastroparesis drug tradipitant did not qualify for a fast-track approval, a federal appeals court affirmed Tuesday.

The US Court of Appeals for the District of Columbia Circuit ruled the Food and Drug Administration reasonably rejected Vanda’s request for an expedited approval process for its drug created to treat severe nausea in patients with gastroparesis.

“By considering all available evidence, the FDA thus lives up to the statutory mandate that it ‘utilize innovative and flexible approaches’ to determine whether to grant fast track status, especially where current data on the drug’s effectiveness may ...