Mylan’s Nod For US Advair Rival Puts It A Year Ahead Of The Pack
The FDA’s approval for Mylan’s Wixela Inhub generic rival to GSK’s Advair Diskus is likely to give the company around a year’s head-start on other US generics being developed by Sandoz and Hikma.
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Sandoz has decided to discontinue development of its generic version of GlaxoSmithKline’s Advair Diskus respiratory brand, resulting in an impairment charge of $442m.
Hikma has submitted a response to the US FDA addressing all outstanding deficiencies in its application for a generic version of GlaxoSmithKline’s Advair Diskus.
Lannett has struck a deal giving it exclusive US distribution rights for 10 years to a generic version of Advair Diskus being developed by China’s Respirent.