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Hikma Pharma Receives CRL From FDA For Generic Advair Diskus; Expects To Get Approval In 2021

Hikma Pharmaceuticals Plc (HIK,HIK.L) said it received a minor complete response letter or CRL from the US Food and Drug Administration or FDA in relation to its abbreviated new drug application or ANDA for its generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

Hikma noted that it is working closely with the FDA to quickly address the small number of questions raised in the CRL. Once answered, Hikma could expect to receive a response from the FDA within 90 days.

Further, the company now expects to receive approval for its generic Advair Diskus in early 2021. As a result, Generics revenue is now anticipated to be in the range of $710 million - $730 million and core operating margin to be in the range of 18% - 19% for 2020 full year.

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