Advair Generic Approval Uncertain Despite US FDA Denial Of Sandoz Petition

While FDA denied Sandoz Inc.'s citizen petition seeking to block approval of generic versions of GlaxoSmithKline PLC's respiratory blockbuster Advair Diskus (fluticasone/salmeterol) it is uncertain when Mylan NV's ANDA will clear the agency. The user fee action date for the application was March 28 but by the end of the day neither the company nor FDA had announced its approval.

In a March 10