Posted by Michael Wonder on 12 May 2021
Liquidia resubmits new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
10 May 2021 - Liquidia Corporation announced today that on 7 May 2021, it resubmitted its new drug application for LIQ861 for the treatment of pulmonary arterial hypertension.
The U.S. FDA issued a complete response letter regarding the new drug application in November 2020 indicating that the application was incomplete and not ready for approval in its present form.
Liquidia and the FDA held a Type A meeting in January 2021 to discuss the complete response letter and the requirements for the new drug application resubmission.
