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Hikma Pharma Completes FDA Response For Generic Advair Diskus

Hikma Pharmaceuticals Plc. (HIK.L, HKMPY.PK) said that it has submitted to the US Food and Drug Administration its response to deficiencies in its abbreviated new drug application for a generic version of GlaxoSmithKline's Advair Diskus.

Hikma initiated a clinical endpoint study in 2018, following receipt of a complete response letter from the FDA.

Siggi Olafsson, Chief Executive Officer of Hikma, said "We are confident in our ability to bring a generic version of Advair to the US market, which would enable us to improve patient access to this important medicine."

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