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.