Benzinga | Jun 2, 2021 07:02AM EDT

Liquidia Announces FDA Acceptance of New Drug Application Resubmission for LIQ861 Inhalation Powder

Liquidia Corporation (NASDAQ:LQDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The FDA confirmed that the resubmission was a complete, class 2 response to the previous action letter issued on November 24, 2020. The FDA set a PDUFA goal date of November 7, 2021.

If the FDA determines, following its substantive review of the NDA, that all requirements for approval have been met, the FDA may issue tentative approval on a timeline generally informed by the PDUFA goal date. Any final FDA approval of the NDA for LIQ861 would be subject to the resolution of the pending Hatch-Waxman litigation commenced by United Therapeutics, and also subject to the FDA's consideration of developments that may have occurred since the time of the tentative approval. The FDA may not issue a final approval until the expiration of a 30-month regulatory stay in October 2022 or an earlier judgment unfavorable to United Therapeutics by the court. A new drug product may not be marketed until the date of final approval which is confirmed by the FDA at the time of final submission.