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Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic

 
• By Jessica Merrill

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

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GlaxoSmithKline PLC's blockbuster asthma treatment Advair Diskus (fluticasone/salmeterol) will have more time on the market alone now that a near-term headwind has been removed. Mylan NV was expecting US FDA action on its ANDA for a generic version of Advair by June 27, but the agency notified the company that it should expect a complete response letter rather than approval.

Mylan told investors after market close June 13 that it expects to receive a CRL from FDA on the June 27 action date, due to what FDA has deemed "minor deficiencies

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