Three Strikes For Generic Advair With An FDA CRL For Sandoz
Novartis' generic drug unit confirmed the receipt of a complete response letter from the US FDA for a generic version of GlaxoSmithKline's Advair, following similar CRLs for Mylan 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.
GlaxoSmithKline is poised for a challenging 2018, with an interchangeable Advair generic expected to launch, but GSK believes growth from new products will make up some of the loss. US Advair sales could be slashed to £750m from £1.6bn in 2017.
After meeting with FDA to discuss the status of its Advair generic application in the US, Mylan said it will not have to conduct additional clinical trials and is on target to respond to the complete response letter soon.