In a letter responding to a citizen petition submitted to the Food and Drug Administration, received on July 8, 2021, that request that the FDA refuse to approve the NDA related to the new drug application for Tyvaso DPI inhalation powder, the FDA stated: “We have carefully considered the Petition and all comments submitted to the docket. For the reasons discussed below, your Petition is denied.” In addition, the FDA stated in the letter that the agency approved NDA 214324 for Tyvaso DPI submitted by United Therapeutics Corporation for the indications of the treatment of pulmonary arterial hypertension and the treatment of pulmonary hypertension associated with interstitial lung disease to improve exercise ability.
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