Posted by Michael Wonder on 29 Mar 2017
Mylan comments on generic Advair Diskus abbreviated new drug application
29 March 2017 - Mylan today commented on the status of its abbreviated new drug application with the U.S. FDA for its generic version of GlaxoSmithKline's Advair Diskus.
In conjunction with Mylan's GDUFA goal date, the company received a complete response letter from FDA regarding its application 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.
