The FDA has finally approved the first generic of GlaxoSmithKline’s Advair blockbuster respiratory diseases inhaler, after years of delays. Even though Advair’s main patent expired in 2010 and ...
But this is likely only a stay of execution for Advair. It’s common for the FDA to reject generics, and with Mylan’s product there is the added complication of producing an inhaler device ...
Looking ahead, Cipla aims to file its generic Advair product application from an alternative site by mid-FY 2025, which could gain approval towards end of next fiscal year if everything goes ...