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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Viatris Acknowledges Potential For US Symbicort Opportunity In 2022
Following its recent landmark approval for the first US generic version of AstraZeneca’s Symbicort blockbuster, Viatris has commented on the potential to move on a pre-patent expiry launch, amid a recent favorable court decision.
Sandoz Will Not Pursue US Advair Rival
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 Addresses Advair Issues In US
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.