United Therapeutics Seeks FDA Approval of Tyvaso DPI

United Therapeutics Seeks FDA Approval of Tyvaso DPI

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United Therapeutics Seeks FDA Approval of Tyvaso DPI

United Therapeutics has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of Tyvaso DPI, a dry powder inhaled formulation of treprostinil, for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). To expedite the process, the company  applied for a priority review voucher by the FDA, which could result in a decision by December. Such accelerated reviews shorten the FDA’s consideration of a new drug application to eight…

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