Hikma completes its FDA response for generic Advair

27 November 2019

London-listed Hikma Pharmaceuticals (LSE: HIK) today announces that it has submitted to the US Food and Drug Administration its response to deficiencies in its Abbreviated New drug Application (ANDA) for a generic version of GlaxoSmithKline’s (LSE: GSK) Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

The generic copy was developed in cooperation with US inhalation specialist Vectura (LSE: VEC). The companies are targeting a launch of their product in 2020, with Vectura due to receive 16% royalty rate on US sales.

Following receipt of a complete response letter (CRL) from the FDA in 2017, and rejected again in March 2018, Hikma initiated a clinical endpoint study in 2018. This study has been completed and it, along with other information requested by the FDA, has been submitted to the FDA for review. The submission addresses the outstanding questions raised by the FDA in its CRL.

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