BRIEF—Mylan says FDA unlikely to approve its generic Advair Diskus

Mylan shares fell 4.3% to $39.90 in after-hours trading yesterday, after the company revealed it has received an update from the US Food and Drug Administration concerning its pending approval for generic Advair Diskus (fluticasone/salmeterol) that FDA has identified minor deficiencies to be relayed in a Complete Response Letter on June 27, 2018.

Because Mylan’s Abbreviated New Drug Application has received a priority designation, the company’s 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,” the company stated.

The news comes as unexpectedly good news for GlaxoSmithKline, which reported revenue of £3.13 billion ($4.19 billion) from Advair last year, and has been bracing for competition at least by mid-2018.