Hikma resumes launch of generic Advair Diskus®

London, 20 April 2021 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has resumed the launch of its generic version of GlaxoSmithKline’s Advair Diskus®[1] in the US following US FDA approval of an amendment Hikma submitted to its Abbreviated New Drug Application in January 2021. The amendment reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA.

Press Release Product 20 April 2021

Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.


Siggi Olafsson, Chief Executive Officer of Hikma, said: “We appreciate the FDA’s timely review and approval of our amendment and are now immediately resuming the launch of our high quality, substitutable generic version of Advair Diskus®. We are very pleased to improve availability of this critical medicine for patients and healthcare providers in the US.”

[1] Advair® and Advair Diskus® are registered trademarks of GSK group of companies.

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.