Anesiva files Zingo NDA with FDA

California, USA-based biopharmaceutical company Anesiva says that it has filed a New Drug Application with the Food and Drug Administration requesting marketing clearance for its needle-free lidocain powder delivery system Zingo. Specifically, the NDA is seeking approval for the product's use as an anasthetic for children undergoing venous access procedures.

The company explained that data from two pivotal studies, that serve as the basis for its submission to the FDA, demonstrated that Zingo provides fast-acting local pain relief in children undergoing intravenous line placements and similar procedures. The firm said that the product was safe and well-tolerated in children, and added that it expects to initiate a similar trial in adult patients early next year.