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.
You may also be interested in...
Company did not kill its development program because of US FDA feedback, but the experience seems to be another lesson in the difficulty in gaining approval for complex generics.
The company's $2.1bn acquisition of Endocyte and expansion into radiopharmaceuticals dominated some of the call, but with the launches of drugs like Cosentyx, Kymriah, Kisqali and Aimovig underway, there was a lot for Novartis' management team to address.
Novartis's proposed sale of its generic oral solids portfolio – which has been battered by US price erosion – and the Sandoz US dermatology business to Aurobindo Pharma, in a deal potentially worth $1bn, allows the unit to finally concentrate on biosimilars, value-added medicines and complex generics.