Link:
Liquidia Corporation announced on March 28, 2025, that the US Food and Drug Administration has accepted its resubmitted new drug application for YUTREPIA (treprostinil) inhalation powder. The treatment targets pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA had previously granted tentative approval for both indications (see our previous article at this link). The agency has set May 24, 2025, as the PDUFA (§) goal date for a final decision.
Liquidia’s CEO, Dr. Roger Jeffs, expressed satisfaction with the FDA’s prompt response to their Monday filing and stated that the company is continuing preparations for a potential launch as soon as possible following final approval.
Read more on the company press release at this link
Footnote
(§) The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration to collect fees from drug manufacturers to fund the new drug approval process. The 1992 law became possible when the Food and Drug Administration and industry agreed on setting target completion times for reviews and the promise these fees would supplement federal appropriations instead of replacing them, the aim being to speed up the process.