FDA rejects United's potential PAH drug due to a manufacturing issue
United Therapeutics said Monday that it received a complete response letter for its potential pulmonary arterial hypertension drug Tyvaso DPI, due to an issue with a third-party facility that performs drug substance testing. The company said it expects an approval will come by next summer.
The inspection issue appears to be the only problem the FDA took notice of, according to United. There were no issues with packaging, manufacturing or testing Tyvaso DPI at the MannKind Corporation facility, the company said.
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