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Hikma resumes launch of generic Advair Diskus®
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LONDON, April 20, 2021 /PRNewswire/ 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.