FDA response delays Hikma's generic Advair Diskus
Hikma Pharmaceuticals lowered its guidance for 2020 on Tuesday, following a response letter from the US Food and Drug Administration (FDA) over the abbreviated new drug application for its generic version of GlaxoSmithKline's ‘Advair Diskus’, or fluticasone propionate and salmeterol inhalation powder, it announced on Tuesday.
The FTSE 100 company said it is working closely with the FDA to quickly address the small number of questions raised in the complete response letter.
Once answered, Hikma said it expected to receive a response from the FDA within 90 days.
“Hikma now expects to receive approval for its generic Advair Diskus in early 2021,” the board said in its statement.
“As a result, generics revenue is now anticipated to be in the range of $710m (£556.16m) to $730m, and core operating margin to be in the range of 18% to 19%, for the 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.”
At 0827 BST, shares in Hikma Pharmaceuticals were down 4.36% at 2,473.36p.