FDA Declines to Approve Tyvaso DPI, Citing Inspection Issue

FDA Declines to Approve Tyvaso DPI, Citing Inspection Issue

309698

FDA Declines to Approve Tyvaso DPI, Citing Inspection Issue

Due to problems at a third-party facility, the U.S. Food and Drug Administration (FDA) has decided to not approve Tyvaso DPI, a dry powder inhaled formulation of treprostinil, at this time. According to United Therapeutics, the medication’s developer, the issue is expected to be dealt with soon. The company anticipates that Tyvaso DPI will be approved to treat both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) by the summer. United applied to the FDA,…

You must be logged in to read/download the full post.