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Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic

 
• By Jessica Merrill

FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.

Watch gears up close

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 to its ANDA for an interchangeable version of 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...

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