13 June 2018 - On the afternoon of June 13, 2018, Mylan received an update from the U.S. FDA concerning our pending approval for generic Advair Diskus that FDA has identified minor deficiencies to be relayed in a complete response letter on 27 June 2018. 

 Because our abbreviated new drug application has received a priority designation, our approval could be received prior to the standard 90-day time period following the date of our response to the complete response letter.

Upon receipt of the official complete response letter, we will determine what, if any, impact that it could have on our full year 2018 outlook.

Read Mylan press release