Mylan NV investors continue to wait for word from US FDA on the status of an application for the first generic version of GlaxoSmithKline PLC's Advair Diskus (fluticasone/salmeterol), a large commercial opportunity. An FDA approval of Mylan's ANDA for generic Advair did not come by its October action date – the third for the product – but management said during the firm's third-quarter sales and earnings call Nov. 5 that it remains confident the application is approvable.
"We are in continuous and ongoing discussions with FDA regarding the progress of the review," President Rajiv Mallik said. "Based...
