United Therapeutics Sues FDA to Toss Liquidia’s Drug Application

The FDA should be ordered to rescind its acceptance of Liquidia Corp.’s amended Yutrepia application that allowed Liquidia to “sidestep” the delay of approval triggered by a new application and related litigation, United Therapeutics Corp. said in a federal lawsuit.

The US Food and Drug Administration “disregarded its own rules, precedents, and procedures” by accepting an amendment from Liquidia “that would do precisely what FDA has always prohibited: add a new indication to its pending application,” according to UTC’s complaint filed Tuesday in the US District Court for the District of Columbia.

• UTC seeks an order that the FDA require ...