Citius Pharmaceuticals Reports Productive FDA Type C Meeting to Discuss Phase 3 Mino-Lok® Program and Pathway to Approval

Core Insights - Citius Pharmaceuticals held a productive Type C meeting with the FDA regarding Mino-Lok, a catheter lock solution aimed at treating central line-associated bloodstream infections [1][2][3] - The FDA provided actionable guidance that supports a future New Drug Application (NDA) submission for Mino-Lok, addressing critical topics such as clinical efficacy and safety data [2][3] - Mino-Lok has shown promising clinical outcomes in its Phase 3 trial, potentially offering a groundbreaking alternative to catheter removal, which could reduce healthcare costs and improve patient outcomes [3][4] Company Overview - Citius Pharmaceuticals is focused on developing first-in-class critical care products, with a late-stage pipeline that includes Mino-Lok and LYMPHIR™, an approved immunotherapy for cutaneous T-cell lymphoma [5] - The company has completed pivotal Phase 3 trials for Mino-Lok and Phase 2b trials for another product, Halo-Lido, in 2023 [5] - Mino-Lok is designed to salvage central venous catheters and is expected to be the first FDA-approved treatment for catheter-related bloodstream infections if approved [4][5]