Mylan’s generic Advair Diskus hits a wall

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Mylan’s generic Advair Diskus hits a wall

By David Salazar - 06/18/2018
The Food and Drug Administration has rejected Mylan’s latest attempt at a generic Advair Diskus, but the drug maker said that it’s still optimistic about receiving approval. Mylan said that the FDA’s Complete Response Letter was issued over “minor deficiencies” that will be explained in full when the agency relays the letter on June 27.

If Mylan can address the FDA’s quibbles, the company said that priority designation granted to its generic application, it might be able to receive approval before the standard 90-day waiting period following its response to the CRL. Until the letter is in-hand, Mylan is staying the course on its financial guidance.

“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,” Mylan said.