It doesn't appear there is going to be a quick fix to get Mylan NV's generic version of GlaxoSmithKline PLC's AdvairDiskus (fluticasone/salmeterol) to market. President Rajiv Malik told investors May 10 that the US FDA's complete response letter to its ANDA for Advair was deemed a "major CRL."
The company's first quarter sales and earnings release was the first chance investors have had to hear publicly from management...