Hikma provides update on generic Advair Diskus® launch

London, 15 January 2021 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has temporarily paused the launch of its generic version of GlaxoSmithKline’s Advair Diskus® [1].

Press Release Inside Information 15 January 2021

Following the US FDA’s approval of Hikma’s Abbreviated New Drug Application (ANDA) for generic Advair Diskus® in December 2020, Hikma has submitted to the US FDA an amendment to its application. The amendment reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application. This amendment will be classified as a Prior Approval Supplement and will not affect the approved status of Hikma’s ANDA for generic Advair Diskus®.

Hikma will work closely with the FDA in its review and will commence distribution of the product once the review has been completed. 


Important notice for users

You are about to access Hikma historic archive material. Any reference in these archives to Hikma products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data, or safety data. Please refer to your approved national product label (SmPC) for current product information.

I have read this warning and will not be using any of the contained product information for clinical purposes.