 WESTLAKE VILLAGE, Calif. and DANBURY, Conn., Oct. 18, 2021 GLOBE NEWSWIRE -- MannKind Corporation Nasdaq: MNKD, a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, has learned that the U.S. Food and Drug Administration FDA issued a complete response to United Therapeutics Corporation regarding the New Drug Application NDA for Tyvaso DPITM for the treatment of pulmonary arterial hypertension PAH and pulmonary hypertension associated with interstitial lung disease PH-ILD. 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 MannKinds facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device. 