D.C. Federal Court Upholds FDA Decision, Allowing Liquidia to Expand Lung Disease Drug’s Use

In a recent legal decision, a D.C. federal court has sided with Liquidia Technologies Inc., affirming a U.S. Food and Drug Administration decision that enables the company to modify its new drug application. This modification allows for the inclusion of an additional indication for a lung disease drug that competes with United Therapeutics Corp.’s widely prescribed Tyvaso. The decision marks a setback for United Therapeutics Corp., which had challenged the FDA’s approval process in an effort to restrict the competitive landscape surrounding its flagship lung disease medication. For further details on this legal battle, you can read the full coverage provided by Law360.