Navigation Links
NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application
Date:8/5/2009

SAN MATEO, Calif., Aug. 5 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date from August 16, 2009 to November 16, 2009 to review the new drug application (NDA) for Qutenza(TM) to manage pain associated with postherpetic neuralgia (PHN).

The extension resulted from the Company's recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline.

Anthony DiTonno, President and CEO, commented, "The FDA's three-month extension is not unexpected. We previously discussed the potential for this extension as a result of our responses to FDA requests for additional information. The information we submitted in July included the report from our recently completed C123 Study, which was performed at the request of the FDA. We believe that with this updated review timeline, if we gain approval in November, we may still achieve our overall goal of launching Qutenza in the United States in the first half of 2010."

Conference Call Details

The Company will hold its quarterly conference call to discuss this recent development as well as financial results for the second quarter of 2009, on August 7, 2009 at 9:00 a.m. ET (6:00 a.m. PT).

To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at '/>"/>

SOURCE NeurogesX, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results
2. NeurogesX Added to Russell 3000 Index
3. NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)
4. NeurogesX to Present at Needham Life Sciences Conference
5. NeurogesX Receives European Commission Approval for Qutenza(TM)
6. NeurogesX Reports First Quarter 2009 Results
7. NeurogesX to Hold Conference Call to Discuss First Quarter 2009 Financial Results
8. NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting
9. NeurogesX to Hold Conference Call to Discuss Fourth Quarter and Year-End 2008 Financial Results and European Regulatory Update
10. NeurogesX Qutenza(TM) (NGX-4010) Receives Positive Committee Recommendation in European Union
11. NeurogesX to Present at 11th Annual BIO CEO & Investor Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... Carahsoft and CDS Federal Services have scheduled ... 2pm EST (11am PST), “Natural Language Processing: Converting Raw ... technology can turn raw, heterogeneous data into actionable knowledge ... online webinar will last approximately one hour. , Synopsis: ...
(Date:1/14/2014)... The largest international professional organization of scientists ... derivatives thereof has endorsed an educational program that ... challenges of adulterated herb and botanical products. ... The Society for Medicinal Plant and Natural Product ...
(Date:1/14/2014)... 2014 Global Record Systems, LLC, ... technology solutions for patients, physicians, the biopharmaceutical industry, ... today the signing of a three-year Research Collaboration ... Administration (FDA). This initiative is designed to ...
(Date:1/14/2014)... Altadena, CA (PRWEB) January 14, 2014 ... Angeles County), California, and Montreal, Canada, has big ideas ... and non-fiction. The press's goals are to produce high-quality, ... e-books to support local businesses. , The first ...
Breaking Biology Technology:Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2Bitingduck Press Looks Forward to 2014 With Multimedia E-books 2
... March 7, 2012 Molecular Detection Inc. (MDI), ... the speed and accuracy of infectious disease diagnosis, ... million financing.  The funds are primarily being used ... the detection of sepsis and gastrointestinal (GI) diseases.  ...
... 2012   Proteonomix, Inc. (OTC/BB: PROT) announced today ... institutional investors, pursuant to which the Company has agreed ... stock at an aggregate purchase price of approximately $3.8 ... shares of Proteonomix common stock) and Series A, Series ...
... including Drexel University,s Dr. Yury Gogotsi has given the ... of the electrodes of supercapacitors the low-cost, lightweight ... many other applications. In a piece published in the ... and his collaborators from universities in France and England, ...
Cached Biology Technology:Molecular Detection Inc. Completes $1.5 Million Financing to Advance New Tests for Sepsis and GI Disorders 2Molecular Detection Inc. Completes $1.5 Million Financing to Advance New Tests for Sepsis and GI Disorders 3Molecular Detection Inc. Completes $1.5 Million Financing to Advance New Tests for Sepsis and GI Disorders 4Proteonomix Announces a Private Placement of $3.8 Million 2Proteonomix Announces a Private Placement of $3.8 Million 3Proteonomix Announces a Private Placement of $3.8 Million 4Drexel's Gogotsi and team advance understanding of energy storage mechanisms in Nature Materials 2
(Date:4/17/2014)... One day about eight years ago, Katia Silvera , ... her father were on a field trip in a mountainous ... they had never seen before. , Unable to identify it, ... The orchid turned out to be an unnamed species. So ... . , "Lophiaris" is the genus name, comprising about 40 ...
(Date:4/17/2014)... of forests in the Amazon help create tinderbox ... rapid and widespread forest loss during drought years, ... show that forests in the Amazon could reach ... forest fires lead to large-scale loss of trees, ... professor of geography, Penn State. , "We documented ...
(Date:4/17/2014)... Current Biology on April 17 have discovered little-known ... insects, which represent four distinct but related species in ... of an animal with sex-reversed genitalia. , "Although ... Neotrogla is the only example in which ... from Hokkaido University in Japan. , During copulation, which ...
Breaking Biology News(10 mins):Orchid named after UC Riverside researcher 2Orchid named after UC Riverside researcher 3Drought and fire in the Amazon lead to sharp increases in forest tree mortality 2Drought and fire in the Amazon lead to sharp increases in forest tree mortality 3In sex-reversed cave insects, females have the penises 2
... Mannitol, a sugar alcohol produced by fungi, bacteria, and algae, ... sweetener is also used in the medical field it,s ... excess fluids and used during surgery as a substance that ... drugs. Now Profs. Ehud Gazit and Daniel Segal of ...
... populations are declining worldwide and a major cause is a ... two-year study shows they can also die from this pathogen, ... that just spreads the disease. When researchers raised the ... least one strain of this pathogen, Batrachochytrium dendrobatidis , ...
... SAN FRANCISCO (June 16, 2013)Male mice who were fed a ... offspring who also had higher levels of body fat, a ... primarily in male offspring, despite their consumption of a low-fat ... Endocrine Society in San Francisco, Calif. , "We,ve identified a ...
Cached Biology News:Artificial sweetener a potential treatment for Parkinson's disease 2Bullfrogs may help spread deadly amphibian fungus, but also die from it 2Obese male mice father offspring with higher levels of body fat 2
MultiWash III w/ 12-portStandard Manifold...
...
... Performance, 5 ml. The same high ... Streptavidin columns for fast, reliable purification ... Tricorn 5/50 GL, XK 16/20, or ... are required.Extremely useful for exploiting either ...
...
Biology Products: