United Therapeutics Corporation contends that the US Food and Drug Administration improperly permitted Liquidia Technologies, Inc. to add a new indication to its pending 505(b)(2) new drug application for Yutrepia (treprostinil) inhalation powder, thereby preventing UTC from obtaining a 30-month stay of approval of the NDA.
Key Takeaways
- UTC lawsuit says FDA improperly accepted an application supplement for a rival to its Tyvaso that neither allows UTC to bring a patent complaint or contains enough clinical data for the agency to review it.
- Without judicial intervention, Liquidia’s version of the pulmonary arterial hypertension drug could be cleared by FDA on 31 March
If approved, the Liquidia product could become a rival to UTC’s Tyvaso, which had US
