Basilea has announced that there will be a minor delay in the timing of its new drug application (NDA) for Zevtera (ceftobiprole) to the FDA and it now anticipates submission in Q323 (previously H123). The decision comes because one of Basilea’s contract manufacturing organisations requires an additional three to six months to adapt its quality control systems before FDA inspection, a prerequisite for NDA review. Following the NDA submission, Basilea expects a regulatory decision on the approval ....
19 Apr 2023
Basilea Pharmaceutica - Zevtera NDA submission pushed to Q323
Sign up to access
Get access to our full offering from over 30 providers
Get access to our full offering from over 30 providers
Basilea Pharmaceutica - Zevtera NDA submission pushed to Q323
Basilea has announced that there will be a minor delay in the timing of its new drug application (NDA) for Zevtera (ceftobiprole) to the FDA and it now anticipates submission in Q323 (previously H123). The decision comes because one of Basilea’s contract manufacturing organisations requires an additional three to six months to adapt its quality control systems before FDA inspection, a prerequisite for NDA review. Following the NDA submission, Basilea expects a regulatory decision on the approval ....