UroGen initiates submission of rolling NDA to FDA for UGN-102

UroGen Pharma announced the submission of the Chemistry, Manufacturing, and Controls CMC section of the New Drug Application NDA for UGN-102 mitomycin for intravesical solution to the U.S. Food and Drug Administration FDA . “The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and CEO, UroGen. “We look forward to working closely with the FDA throughout the review process and remain steadfast in our commitment to address unmet medical needs in the uro-oncology space and advance patient care.” The objective of the rolling NDA for UGN-102 is to facilitate early engagement with the FDA, and a more efficient and timely review of the NDA. Based on its agreement with the FDA, UroGen will complete the submission of the rolling NDA for UGN-102 in 2024 with a potential FDA decision as early as the first quarter of 2025.