Navigation Links
FDA Accepts Zingo(TM) Supplemental New Drug Application to Reduce Pain Associated With Peripheral Needle Insertion Procedures in Adults
Date:5/21/2008

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.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
2. FDA Accepts Sucampos sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
3. FDA Accepts Ranexa(R) sNDA and NDA for Filing
4. EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes
5. Imaging Diagnostic Systems Accepts Resignations of Outside Directors
6. U.S. Government Accepts $192 Million of sanofi pasteur H5N1 Bulk Vaccine Antigen for Pandemic Stockpile
7. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
8. Anesiva to Host Conference Call and Webcast Tomorrow to Discuss Encouraging Development in Zingo(TM) Program
9. Anesiva Signs Co-Promotion and Distribution Agreement With Sagent Pharmaceuticals for Zingo(TM) in U.S. Hospitals
10. Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)
11. Anesiva Announces Submission of Supplemental New Drug Application for Zingo(TM) to Reduce Pain Associated With Needle Insertion Procedures in Adults
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... Louis, MO (PRWEB) August 21, 2014 ... full service biopharmaceutical contract development and manufacturing organization ... by Progenics Pharmaceuticals, Inc., an oncology company focused ... and treating cancer, to manufacture the anti-prostate specific ... PSMA ADC product candidate. Under the agreement ...
(Date:8/20/2014)... RALEIGH, N.C. , Aug. 20, 2014 /PRNewswire/ ... clinical research services located in Raleigh, ... Bradford Evans as Vice President of ... Administration, Brad will oversee all corporate processes, including ... to joining Clintrax Global, Brad worked as an ...
(Date:8/20/2014)... time, chemists have succeeded in measuring vibrational motion of ... study reveals how vibration of a single molecule differs ... The study was performed at the University of California, ... of Jyvskyl works as a visiting fellow under professor ... The second team was lead by Professor Eric O. ...
(Date:8/20/2014)... 20, 2014  Decision Resources Group finds that the vascular access ... , India and China ... roughly equal to the size of the United States ... will experience much faster growth as a result of strong economic ... Other key findings from Decision Resources Group,s coverage of the BRIC ...
Breaking Biology Technology:Gallus Enters Agreement with Progenics Pharmaceuticals, Inc. for Manufacture of Anti-PSMA Monoclonal Antibody 2Gallus Enters Agreement with Progenics Pharmaceuticals, Inc. for Manufacture of Anti-PSMA Monoclonal Antibody 3Clintrax Global, Inc. Announces Addition to Executive Team 2Seeing a molecule breathe 2BRIC Vascular Access Device Market Valued at $1.6 Billion in 2013, Similar to the U.S. Market 2BRIC Vascular Access Device Market Valued at $1.6 Billion in 2013, Similar to the U.S. Market 3
... Life Sciences,Holdings, Inc. (Nasdaq: ADLS ), ... and commercialization of novel drugs in the,therapeutic ... today,announced that it was added to the ... reconstituted its comprehensive set of U.S. and,global ...
... 3 /Xinhua-PRNewswire-FirstCall/ -- Huifeng,Bio-Pharmaceutical Technology, Inc. (OTC ... of plant extracts and pharmaceutical raw materials,for ... in China,announced today that its company information ... Market Access Program, an information distribution,service that ...
... to offer choice of two distinct drugs on ... separate drug-eluting stent platforms, NATICK, ... today announced that the U.S. Food and Drug,Administration (FDA) has ... coronary artery disease. The,PROMUS Stent is a private-labeled XIENCE(TM) V ...
Cached Biology Technology:Advanced Life Sciences Added to Russell Microcap Index 2Advanced Life Sciences Added to Russell Microcap Index 3Huifeng Bio-Pharmaceutical (HFGB) Information to Be Available Through Standard & Poor's Market Access Program 2Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus-Eluting Coronary Stent System 2Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus-Eluting Coronary Stent System 3Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus-Eluting Coronary Stent System 4
(Date:8/20/2014)... University of Tennessee, Knoxville, research finds life can persist ... professor was part of a team that examined waters ... Antarctic ice sheet and found the extreme environment supports ... by Jill Mikucki and her colleagues has implications for ... in the solar system. The findings are published in ...
(Date:8/20/2014)... VALLEY, Calif., August 19, 2014 -- Bay Area Lyme ... diagnose and simple to cure, applauds new research published ... journal Ticks and Tick-borne Diseases . The ... Northwest California are active throughout the year, making the ... by researchers at California Department of Public Health (CDPH) ...
(Date:8/20/2014)... chili pepper causes a burning spiciness that is irresistible ... chili pepper,s effect are using their findings to develop ... which can be caused by inflammation or other problems. ... being tested in clinical trials, in ACS, Journal ... explain that decades ago, scientists had pegged a compound ...
Breaking Biology News(10 mins):University of Tennessee research uncovers subglacial life beneath Antarctic ice sheet 2Lyme disease risk is year-round in Northwest California, according to new study 2Lyme disease risk is year-round in Northwest California, according to new study 3
... by LSU Associate Professors of Biological Sciences Fernando Galvez and ... and laboratory study showing the effects of the Deepwater Horizon ... , The study, funded in part by the National Science ... is being published in the journal Proceedings of the ...
... Alzheimer,s disease rises and falls in the spinal fluid in ... Washington University School of Medicine in St. Louis have found. ... and reinforces a link between increased Alzheimer,s risk and inadequate ... brain,s relative inactivity during sleep may provide an opportunity to ...
... Steve Bergens and his graduate student Jeremy Johns ... to revolutionise the chemical industry by reducing its ... Their findings were published in a top international ... the chemical industry with a potential solution to ...
Cached Biology News:LSU researchers find impact of oil spill in marsh fish species 2Marker for Alzheimer's disease rises during day and falls with sleep 2Marker for Alzheimer's disease rises during day and falls with sleep 3Catalyst discovery has potential to revolutionize chemical industry 2
Piperazine-N',N'-bis(2-ethanesulfonic acid), monosodium salt...
... receptors constitute the principal excitatory ... classes of glutamate receptors exist: ... Ionotropic glutamate receptors are oligomeric ... NMDA1-3, KAI-2) which comprise ligand-gated ...
Recommended fro Western blotting application...
... Anti-Krueppel-like factor 15 (KLF15) KLF15 is ... found abundantly expressed in the liver, kidneys, ... NP_054798 Specificity: Polyclonal antibody produced in ... to a region of human KLF15 with ...
Biology Products: