Novartis had not been frontrunner to receive approval for its generic version of GSK’s Advair – lagging behind Mylan’s generic and a Hikma and Vectura partnership product. However, both went in front of the FDA and found their versions hit by CRLs.
For Novartis, it could not have panned out any better. It had suddenly jumped to the front of the queue and would be only the second company to bring its generic version of the blockbuster drug, behind Teva.