Hikma provides update on status of ANDA for generic Advair Diskus®

London, 22 September 2020 – Hikma Pharmaceuticals PLC (Hikma or the Group), the multinational pharmaceutical company, announces that it has received a minor complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for its generic version of GlaxoSmithKline’s Advair Diskus®[1] (fluticasone propionate and salmeterol inhalation powder).

Press Release Corporate 22 September 2020

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Hikma is working closely with the FDA to quickly address the small number of questions raised in the CRL. Once answered, Hikma can expect to receive a response from the FDA within 90 days. Hikma 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 to $730 million and core operating margin to be in the range of 18% to 19% for 2020 full year.

Hikma and its partner Vectura Group, are committed to bringing this important product to the US market and remain confident in the submission.

[1] Advair® and Advair Diskus® are registered trademarks of Glaxo Group Limited.

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