Citius Pharmaceuticals reports ‘constructive’ FDA Type C meeting on Mino-Lok

Citius Pharmaceuticals (CTXR) announced that the company held a constructive in-person Type C meeting with the U.S. FDA. The meeting followed successful completion of the company’s pivotal Phase 3 clinical trial of Mino-Lok, a novel catheter lock solution designed to salvage central venous catheters in patients suffering from central line-associated bloodstream infections or catheter-related bloodstream infections. The primary discussion centered on responses to the FDA’s questions related to Mino-Lok’s clinical trial data and a pathway to a future submission. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application submission for Mino-Lok. The meeting encompassed an extensive range of topics critical to the NDA process, including in-vitro, clinical efficacy and safety data, and regulatory considerations. Citius Pharma reaffirmed the potential of Mino-Lok to address a critical unmet medical need and its commitment to advancing the program. “We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program,” stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. “The FDA’s comprehensive feedback supports our commitment to advancing this novel solution for patients who face life-threatening complications from catheter-related infections. The Agency’s guidance provides a strong framework for completing the remaining steps toward an NDA submission.”