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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.'

lung illustration

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."

The company's first quarter sales and earnings release was the first chance investors have had to hear publicly from management since the complete response letter was issued in March. (Also see "Mylan’s Generic Advair Delay Gives Leverage To Rivals" - Pink Sheet, 30 March, 2017

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