The FDA has accepted Sandoz’s submission of its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination, a generic for Advair Diskus. The FDA has already rejected two applications from Mylan and Hikma for their Advair generics this year. Advair is manufactured by GlaxoSmithKline (GSK).
However, Pharmaphorum.com reports that “it looks like Sandoz could succeed where its rivals have failed.”
If approved, Sandoz’s drug will treat asthma in patients aged four years and older and provide maintenance treatment of airflow obstruction and reducing exacerbations in COPD.