United Therapeutics sues FDA over handling of Liquidia’s new drug application for treprostinil

Unit­ed Ther­a­peu­tics is su­ing the FDA over how the agency han­dled Liq­uidia’s new drug ap­pli­ca­tion for its ver­sion of tre­pros­tinil, an in­haled pow­der that treats pul­monary ar­te­r­i­al hy­per­ten­sion.

In a 49-page com­plaint filed Tues­day in the US Dis­trict Court for DC, Unit­ed makes the case that the FDA mis­han­dled a new drug ap­pli­ca­tion for tre­pros­tinil filed by its com­peti­tor Liq­uidia, which Liq­uidia amend­ed while it was still pend­ing to in­clude an in­di­ca­tion for pul­monary hy­per­ten­sion as­so­ci­at­ed with in­ter­sti­tial lung dis­ease (PH-ILD).

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.