Posted by Michael Wonder on 28 Nov 2019
Hikma completes its FDA response for generic Advair
27 November 2019 - Hikma Pharmaceuticals today announces that it has submitted to the US FDA its response to deficiencies in its abbreviated new drug application for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
Following receipt of a complete response letter (CRL) from the FDA, Hikma initiated a clinical endpoint study in 2018. This study has been completed and it, along with other information requested by the FDA, has been submitted to the FDA for review.
The submission addresses the outstanding questions raised by the FDA in its CRL.
