Citius Pharmaceuticals Reports Productive FDA Type C Meeting for Mino-Lok Phase 3 Program

Citius Pharmaceuticals, Inc.

Citius Pharma held a constructive in-person Type C meeting with the FDA on November 25, 2024, regarding its Phase 3 Mino-Lok trial for catheter-related bloodstream infections.
The FDA provided clear, actionable guidance on clinical efficacy and safety data, supporting a pathway to a future New Drug Application (NDA) submission.
Chairman and CEO Leonard Mazur stated the Agency's comprehensive feedback provides a strong framework for completing remaining steps toward an NDA.
Mino-Lok, if approved, could reduce healthcare costs and improve outcomes by salvaging central venous catheters instead of removing them.

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