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Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns

 
• By Jessica Merrill

Dispute over analysis of inhaler device could delay launch of competitor to GSK's franchise until 2018; FDA's complete response letter to Mylan' deemed 'major.'

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It doesn't appear there is going to be a quick fix to get Mylan NV's generic version of GlaxoSmithKline PLC's AdvairDiskus (fluticasone/salmeterol) to market. President Rajiv Malik told investors May 10 that the US FDA's complete response letter to its ANDA for Advair was deemed a "major CRL."

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