United Therapeutics Draws CRL for Drug-Device Combination

By PacConAdmin | November 1, 2021

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.
Source: Drug GMP Report

Posted in Drug GMP Report