Cormedix Leads Limited Pipeline For US FDA’s LPAD Pathway

Cormedix prepares NDA submission for Neutrolin for prevention of catheter-related blood stream infections, aiming to become the third approval under the US FDA’s Limited Population Pathway.

CorMedix Inc. is gearing up to try for approval of its catheter lock solution Neutrolin under the US Food and Drug Administration’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), a still relatively unused regulatory mechanism that allows for streamlined clinical development for drugs to treat serious or life-threatening infections in a limited population with unmet needs.

Cormedix is preparing a rolling NDA submission for Neutrolin for prevention of catheter-related blood stream infections (CRBSIs) in hemodialysis patients,...