FDA rejects Mylan's generic version of GlaxoSmithKline's inhaled asthma drug Advair

Mylan announced Wednesday that it received a complete response letter from the FDA regarding its regulatory filing to market a generic version of GlaxoSmithKline's Advair Diskus (fluticasone/salmeterol). Mylan did not specify the reason behind the rejection, saying it is "in the process of reviewing this response and will provide an update on its application as soon as practicable." 

The agency, which accepted Mylan's filing for a generic version of Advair Diskus in February 2016, had been expected to render its decision by March 28.

Commenting on the news, Evercore ISI analyst Umer Raffat indicated that a citizen petition filed by Novartis' Sandoz unit questioning Mylan's low-dose product may have hurt the latter's drug application. "Had the FDA denied the…petition outright, it may have implied that the FDA does not deem Sandoz's point to be important, and the odds of generic approval today would have been higher," Raffat stated, "but that didn't happen." The analyst also suggested that Mylan's Phase III study backing the submission was also dated.