Mylan gets complete response letter for generic Advair ANDA

Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing the CRL and will comment further once it has discussed it with the FDA.

In February 2016, Mylan announced that the FDA had accepted its ANDA for the fluticasone/salmeterol DPI with a GDUFA date of March 28, 2017.

In October 2016, Sandoz filed a citizen petition with the FDA challenging the agency’s bioequivalence recommendations for generic versions of Advair Diskus and asking the FDA to not approve any ANDA referencing Advair Diskus 100/50 unless PK testing met more stringent standards.

Just before the GDUFA date for Mylan’s ANDA, the FDA released a letter to Sandoz formally denying the petition but saying that it was not commenting on whether it would agree to act as requested, leading to speculation that the agency would not approve Mylan’s generic.

Read the Mylan press release.