Mylan Sees Generic Advair Marathon Nearing FDA Finish Line

 
• By Jessica Merrill
  
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Company management expressed confidence its application for the first generic Advair is approvable, although the US agency didn’t clear it in October as Mylan had hoped. 

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Mylan NV investors continue to wait for word from US FDA on the status of an application for the first generic version of GlaxoSmithKline PLC's Advair Diskus (fluticasone/salmeterol), a large commercial opportunity. An FDA approval of Mylan's ANDA for generic Advair did not come by its October action date – the third for the product – but management said during the firm's third-quarter sales and earnings call Nov. 5 that it remains confident the application is approvable.

"We are in continuous and ongoing discussions with FDA regarding the progress of the review," President Rajiv Mallik said. "Based...

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