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Home » United Therapeutics Draws CRL for Drug-Device Combination
United Therapeutics Draws CRL for Drug-Device Combination
In a Complete Response Letter to United Therapeutics, the FDA declined to approve the company’s Tyvaso DPI (treprostinil) drug-device combination for improving exercise capacity in patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.