Update of Advair from Generics Bulletin March 202125 Mar 2021 10:38
Advair Rival Awaits FDA Action On ANDA Supplement
Providing the latest update on Hikma’s generic rival to Advair – which was approved late last year and was about to be introduced to the market, only for the launch to be halted by the need for an amendment to the abbreviated new drug application to reflect enhanced packaging controls (Also see "Hikma Suspends Roll-Out Of Advair Rival" - Generics Bulletin, 18 Jan, 2021.) – Olafsson commented that “we really just paused the launch of this product.”
“The review time of our generic Advair application was a long one, it was nearly five years,” Olafsson explained, with Hikma and development partner Vectura having received multiple complete response letters from the US Food and Drug Administration linked to the ANDA. “And during that time, there are obviously multiple updates that you need to do, science has moved on, and in this case our analytical method for the primary packaging material had moved on in [terms of the] science. So the FDA asked us to submit this as a pre-approval supplement.”
Asked whether this process was seen as a formality for the product, Olafsson said “we are very confident we have submitted all the data [and] the FDA granted us a priority review of the PAS. So it is a timing issue, I wouldn’t expect this to be a risk for the product in any way or form.”
Pressed on whether Hikma had specific expectations on when it would be able to resume launch activities for its generic, he said “it’s always difficult to guess on the timing from the FDA – you’re probably always wrong when you guess it – but I think second quarter, even though we are not guiding towards that, sometime in the second quarter wouldn’t be an unreasonable time to think about the launch.”