The U.S. FDA has rejected Mylan's generic version of GlaxoSmithKline's best-selling asthma treatment, Advair.
Advair has brought GSK more than $1 billion in annual sales every year since 2001.
According to Mylan, in conjunction with its GDUFA goal date, the company received a complete response letter from FDA regarding its ANDA for generic Advair Diskus. Mylan is in the process of reviewing this response and will provide an update on its application as soon as practicable once it has completed its review and discussed the FDA's feedback with the agency.
Read the Mylan press release