Posted by Michael Wonder on 25 Sep 2023
FDA issues complete response letter for Udencya Onbody biologics license application solely due to an on-going review of inspection findings at a third-party filler
25 September 2023 - No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified in the Udencya Onbody complete response letter.
Coherus BioSciences announced today that the US FDA issued a complete response letter regarding the biologics license application supplement for Udencya Onbody, the company's on-body injector presentation of Udencya (pegfilgrastim-cbqv), solely due to an on-going review of inspection findings at a third-party filler.
