Mannkind (MNKD): FDA declines to approve lung drug

 

 

 

Mannkind provides up on Tyvaso DPI NDA

• MannKind Corporation has learned that the FDA issued a complete response to United Therapeutics (UTHR) regarding the New Drug Application (NDA) for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
• The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil drug substance, the active ingredient of Tyvaso DPI. The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind's facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device.