United Therapeutics (UTHR), MannKind (MNKD) Announces FDA Acceptance of Tyvaso DPI NDA For Priority Review

Go back to United Therapeutics (UTHR), MannKind (MNKD) Announces FDA Acceptance of Tyvaso DPI NDA For Priority Review

United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review

June 16, 2021 6:00 AM EDT

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 16, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency's review to be complete in October 2021. FDA also indicated that they have not identified any potential review issues at this... More