Facility Inspection Issue Stalls FDA Approval of Tyvaso DPI for PH-ILD

Facility Inspection Issue Stalls FDA Approval of Tyvaso DPI for PH-ILD

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Facility Inspection Issue Stalls FDA Approval of Tyvaso DPI for PH-ILD

An open inspection issue at a third-party testing facility has put on hold United Therapeutics’ application seeking the approval of Tyvaso DPI, an investigational dry powder inhaled formulation of treprostinil for pulmonary hypertension associated with interstitial lung disease (PH-ILD), a group of disorders that also includes idiopathic pulmonary fibrosis (IPF). Efforts are underway to resolve the issue — as identified by the U.S. Food and Drug Administration (FDA) — at the facility, which was conducting analytical testing…

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