Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug application for UGN-102 (mitomycin) for intravesical solution to the US FDA.
Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates completing its new drug application submission for UGN-102 in 2024 with a potential FDA decision as early as the first quarter of 2025.
