FDA letter sets back Hikma's generic Advair Diskus
Hikma has received a minor complete response letter from the Food and Drug Administration in relation to the abbreviated new drug application for its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
Hikma said that it is working closely with the FDA to quickly address the small number of questions raised in the letter.
It expects 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 the full-year 2020.