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ANX-016 (vancomycin emulsion) ANX-016 is a novel formulation of vancomycin, a parenteral glycopeptide antibiotic approved to treat most Gram-positive bacteria, including Streptococci, Corynebacteria, Clostridia and Listeria. In severe bacterial infections an intravenous (IV) infusion may be necessary. ANX-016 is designed to reduce vein irritation and phlebitis associated with IV-delivery of the drug. The Company is currently conducting preclinical pharmacokinetic testing of ANX-016 to compare this product candidate with the approved version of the product and plans to seek guidance from the FDA in 2007 with respect to the appropriateness of a Section 505(b)(2) NDA regulatory path. |
