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FDA Sued Over Fast-Track Denial for Digestive Disorder Drug

May 23, 2022, 8:04 PM

The FDA improperly denied fast-track approval for a drug to treat a chronic digestive disorder based on a premature judgment that the drug wouldn’t be able to win final marketing clearance, drugmaker Vanda Pharmaceuticals said in a lawsuit.

The denial was based on “impermissible speculation” rather than on the central criterion of the law that created fast-track approval: whether the drug shows the potential to address unmet medical needs, Vanda alleged in the lawsuit filed Monday in the US District Court for the District of Columbia.

The drug at issue is tradipitant, which Vanda says has shown “exceptional promise” in ...