Hikma resumes launch of generic Advair Diskus
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.
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.”
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