Sandoz Will Not Pursue US Advair Rival
Discontinuing Development Leads To $442m Impairment
Sandoz has decided to discontinue development of its generic version of GlaxoSmithKline’s Advair Diskus respiratory brand, resulting in an impairment charge of $442m.
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Hikma has gained FDA approval for and launched its long-in-development generic version of Advair Diskus. The milestone puts it in direct competition with Viatris’ Wixela Inhub version that was launched almost two years ago, in three presentations compared to Hikma’s two.
Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.
Lannett has partnered with China’s Respirent for a generic version of GlaxoSmithKline’s Flovent Diskus. At the same time, the US company has extended its exclusive US distribution rights for Respirent’s Advair Diskus rival from 10 years to 12 years, as Lannett remains on track to file its ANDA this calendar year.