Tyvaso DPI Earns FDA Priority Review Status

Tyvaso DPI Earns FDA Priority Review Status

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Tyvaso DPI Earns FDA Priority Review Status

The U.S. Food and Drug Administration (FDA) has granted priority review status to the application seeking approval of Tyvaso DPI — a dry powder inhaled formulation of treprostinil — for the treatment of both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Priority review shortens the FDA’s review period to eight months, down from the standard one year. United Therapeutics, developers of Tyvaso DPI and other treprostinil formulations including Tyvaso (inhaled), Orenitram (oral), and Remodulin…

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