Posted by Michael Wonder on 22 Sep 2020
Hikma updates on ANDA for generic Advair Diskus
22 September 2020 - Hikma Pharmaceuticals announces that it has received a minor complete response letter from the US FDA in relation to its abbreviated new drug application for its generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
Hikma is working closely with the FDA to quickly address the small number of questions raised in the complete response letter.
