Mylan announced that the FDA will not approve its Abbreviated New Drug Application for the generic version of GlaxoSmithKline's asthma drug, Advair Diskus, due to “minor deficiencies” in the application.
The deficiencies will be relayed in a Complete Response Letter on June 27, 2018. This is the second CRL Mylan has received from the FDA regarding its ANDA for a generic version of GSK’s best-selling asthma treatment — the first one was announced in March of last year.
According to Mylan, however, the damage isn’t that bad: because its ANDA has received a priority designation, approval could be received prior to the standard 90-day time period following the drugmaker's response to the Complete Response Letter.
Read the press release