Leonard Meron Biosciences announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for the antimicrobial lock solution, Mino-Lok (minocycline-EDTA-EtOH), to salvage and sterilize infected central venous catheters (CVCs) in patients with bacteremia.
The lock solution technology was developed at The University of Texas MD Anderson Cancer Center by Dr. Issam Raad, the G. P. Bodey, Sr., Distinguished Professor and Chair, Department of Infectious Diseases, Infection Control and Employee Health.
Receiving QIDP designation means that Mino-Lok is now eligible for additional FDA incentives for approval and marketing, including Fast Track designation and Priority Review, and a five-year extension of market exclusivity. The company intends to begin Phase 3 trials for Mino-Lok early next year.
For more information visit FDA.gov.