Hikma Pharmaceuticals PLC (LON:HIK), the multinational pharmaceutical company, has announced 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 Pharmaceutical, 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.