8 February 2018 - Sandoz unit will provide agency with details on Advair copy.
GlaxoSmithKline Plc’s asthma drug Advair won some room to run as U.S. regulators denied approval to rival Novartis AG’s generic version of the blockbuster treatment.
Glaxo extended its gains in London trading Thursday, rising as much as 3.6%, after Novartis said its Sandoz unit received a notification from the FDA that its application wasn’t approved in its current form. The regulator’s requests include requirements to submit additional data, the Swiss drugmaker said in an emailed statement.