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® (fluticasone propionate and salmeterol inhalation powder).
22 September 2020
Press Release, Product
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.
 Advair® and Advair Diskus® are registered trademarks of Glaxo Group Limited.