FDA Declines to Approve Generic Version of Advair Diskus––for Now

Mylan keeps reason for rejection under wraps

Mylan has reported on the status of its abbreviated new drug application with the FDA for its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). The company states that it has received a complete response letter (CRL) from the FDA and is in the process of reviewing the agency’s comments.

Mylan provided no details regarding the FDA’s concerns or how long the product might be delayed.

The CRL has given GlaxoSmithKline additional time to sell Advair Diskus without competition from a cheaper generic. According to Reuters, Advair has generated more than $1 billion in sales each year since 2001.

Another generic version of Advair––from Hikma Pharmaceuticals––is awaiting an FDA approval decision by May 10.

Sources: Mylan; March 29, 2017; and Reuters; March 29, 2017.