Drug Development
Anesiva Announces Submission of Supplemental New Drug Application for Zingo(TM) to Reduce Pain Associated With Needle Insertion Procedures in Adults
Published in Surgery Litigation and Law Weekly, March 28th, 2008
Anesiva, Inc. (NASDAQ:ANSV) announced that the company has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to expand the indication for Zingo to treat the pain associated with peripheral IV insertions and blood draws in adults. Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system is already approved by the FDA to provide local analgesia prior to peripheral IV insertions and blood draws in children three to 18 years of age.
The sNDA submission is based on results of a multi-center, randomized, double-blind study in 699 adult patients, which demonstrated less procedural pain associated...
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