Anesiva, Inc. (Nasdaq: ANSV) filed a New Drug Application (NDA) to the USFDA for the marketing clearance of Zingo™ to treat the pain associated with venous access procedures in children.
Zingo™, previously known as 3268, is a fast-acting, local anesthetic which has been (from two previous pivotal Phase 3 trials) to provide statistically significant pain relief in children undergoing venous access procedures, such as intravenous (IV) line placements.
Such clinical data served as the foundation of the submitted NDA.
The said NDA was field by Anesiva using the Common Technical Document (CTD) format, which can be reviewed by both the USFDA and international regulatory authorities for domestic and international registration of new therapeutics.
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