The Food and Drug Administration has accepted United Therapeutics' application to add idiopathic pulmonary fibrosis (IPF) to the approved uses of nebulized Tyvaso, starting a review the company expects to be completed in late April 2027. The company's announcement of the FDA filing acceptance, issued September 2, stressed that the inhaled drug has not been approved for IPF and remains investigational for that use.
Acceptance is a procedural step, not a verdict. It means the FDA considers the supplemental new drug application complete enough to review. The late April timeline is the company's stated expectation, and the agency could approve the drug, request more information, or decline to approve it.
