Mylan awaits further Advair CRL

Executive Summary

Mylan will receive a second complete response letter (CRL) refusing US approval for the firm’s Wixela Inhub generic version of Advair Diskus (fluticasone/salmeterol), the firm has revealed. The US Food and Drug Administration (FDA) will communicate “minor deficiencies” identified in the company’s abbreviated new drug application (ANDA) in a CRL on 27 June, the ANDA’s target action date. No details on the nature of the CRL were revealed by Mylan or the FDA. “Because our ANDA has received a priority designation, our approval could be received prior to the standard 90-day time period following the date of our response to the CRL,” Mylan observed. Upon receipt of the CRL, Mylan said it would determine “what, if any, impact that it could have on our full-year 2018 outlook”.