Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan’s ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June 27, 2018.
According to Mylan, the reason for the CRL is that the FDA “has identified minor deficiencies.” Mylan received a previous CRL for its generic Advair Diskus in March 2017.
The company noted that, “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.”
In December 2017, Mylan filed a citizen petition requesting that the FDA not approve any ANDA for a generic version of Advair Diskus relying on data from multiple-batch PK bioequivalence studies “unless, after conducting an appropriately rigorous review under the established standards for establishing BE, generally, and for this product specifically, FDA concludes that such a study design is valid and will ensure patients receive a robust and reliable therapeutically equivalent product.”
Read the Mylan press release.
