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Mylan fails to win US FDA approval for generic version of GSK's Advair Diskus

The U.S. FDA rejected Mylan NV's abbreviated new drug application for its generic version of GlaxoSmithKline plc's lung disease drug Advair Diskus.

Mylan is in the process of reviewing the complete response letter from the agency and will give an update once the review is finished and it has discussed the feedback with the regulator.