SOUTH SAN FRANCISCO, Calif., May 21 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's electronic supplemental New Drug Application (sNDA) filing to expand the indication for Zingo to treat 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.
Acceptance for filing of a sNDA means that the FDA has found the company's submission to be sufficiently complete to review. This review is a standard review, and under the Prescription Drug User Fee Act (PDUFA), the agency makes a decision regarding marketing clearance of a product candidate within 10 months of the date of its submission. The sNDA for Zingo was submitted on March 10, 2008.
"As we approach the commercial launch of Zingo in the pediatric population in June, FDA's acceptance of our sNDA filing for adults marks another significant step forward for growing the Zingo franchise," said John P. McLaughlin, chief executive officer of Anesiva. "We believe that Zingo can offer significant relief to adults who experience pain upon peripheral venous access procedures, not only in the United States but also worldwide."
Venous access procedures, like IV insertions and blood draws, are among the most common procedures performed at a hospital. In 2004, more than 245 million adult peripheral venous access procedures and more than 18 million pediatric peripheral venous access procedures were performed in hospitals in the United States.(1)'/>"/>
|SOURCE Anesiva, Inc.|
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