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# Liquidia NDA Resubmission Accepted for Review
- URL: https://www.fdaweb.com/liquidia-nda-resubmission-accepted-for-review/
- Published: 2021-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:01:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149447

FDA has accepted for review a Liquidia NDA resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The agency has confirmed that the resubmission was a complete, Class 2 response to a 11/24/2020 complete response letter and has set a user fee review action target date of 11/7.

The complete response letter indicated a need for additional information and clarification on chemistry, manufacturing, and controls data on the drug product and device biocompatibility, the company [said](https://www.globenewswire.com/news-release/2020/11/25/2133620/0/en/Liquidia-Receives-Complete-Response-Letter-from-FDA-for-LIQ861-treprostinil-Inhalation-Powder-for-the-Treatment-of-Pulmonary-Arterial-Hypertension.html?ref=fdaweb.com) at the time. Liquidia and the agency held a Type A meeting in January to discuss the requirements for the NDA resubmission. FDA also reconfirmed the need to conduct on-site pre-approval inspections, which were delayed due to Covid-19 restrictions, at two of the company’s U.S. manufacturing facilities before the NDA can be approved. No additional data from clinical trials or studies related to toxicology or clinical pharmacology were required, the company says.

Liquidia says LIQ861 is an investigational inhaled dry powder formulation of treprostinil designed using Liquidia's PRINT technology that is intended to enhance deep-lung delivery using a palm-sized dry powder inhaler.