Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Int... ( RICHMOND Calif. June 11 /- Transcept ...)

Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo(R)

Date:6/11/2009

RICHMOND, Calif., June 11 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.

In the normal course of the Intermezzo(R) NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the Transcept response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

Glenn A. Oclassen, President and Chief Executive Officer, commented, "Although we have not yet received a formal written notification from the FDA, our conversations with them indicate that additional review time for the Intermezzo(R) NDA will be necessary. We felt it our responsibility to inform shareholders in advance of a formal FDA notification and will update our shareholders as appropriate after such notice is received."

Mr. Oclassen added, "We appreciate the willingness of the FDA to take the time necessary to fully consider our recent amendment to the Intermezzo(R) NDA. We remain confident in the strength of our regulatory submissions and look forward to working with the FDA as it completes its review. Our goal remains to provide a new and important therapeutic for those patients who suffer from middle of the night awake
'/>"/>

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

0

GOOD

Post Your Comments:

(Date:5/19/2013)... (PRWEB) May 20, 2013 Due to ... with online advertising, MileageAds.com has decided to invite bloggers ... through their ad network. , Businesses in the ... success with online marketing, specifically with ad networks. ... information and legal services and are unsure where to ...

(Date:5/19/2013)... physicians are key decisionmakers for nearly half of all ... in reducing health care costs, according to a new ... admissions from the ER increased by 17 percent over ... hospital admissions between 2003 and 2009. Hospital inpatient ... accounting for 31 percent of the nation,s health care ...

(Date:5/19/2013)... New York, NY (PRWEB) May 19, 2013 ... tickets for his two concerts in Vegas in October ... 20th. Additionaly, during the spring and summer months of ... the country. , Whenever people hear “It’s Five ... and hear the voice of Jimmy Buffett inside their heads. ...

(Date:5/19/2013)... (PRWEB) May 19, 2013 Daily Gossip reporters ... 17 Cheat Foods That Burn Fat to a ... readers. , The review is a detailed ... by the writer's recommendation. , The two nutritionists have discovered ... is responsible for the caloric intake and expenditure of our ...

(Date:5/19/2013)... May is officially known as Skin Cancer Awareness ... Australia, the country's forerunner in fashionable children’s sun ... to kick off their month long mission to bring ... staggering number of cancer cases diagnosed each year, the ... out what’s causing the epidemic and how to stop ...

Breaking Medicine News(10 mins):Health News:Mileageads Ad Network Now Invites Bloggers and Business Owners in Mesothelioma Sector to Advertise on Their Ad Network 2 Health News:ER docs are key to reducing health care costs 2 Health News:ER docs are key to reducing health care costs 3 Health News:Jimmy Buffett Las Vegas Tickets: Jimmy Buffett Tickets in Vegas at the MGM Grand on Oct. 19 and Oct. 26 Go on Public Sale Monday, May 20 at 10:00 a.m. Local Time 2 Health News:Jimmy Buffett Las Vegas Tickets: Jimmy Buffett Tickets in Vegas at the MGM Grand on Oct. 19 and Oct. 26 Go on Public Sale Monday, May 20 at 10:00 a.m. Local Time 3 Health News:The "17 Cheat Foods That Burn Fat" Review and Diet Plan Secrets Revealed by Daily Gossip 2 Health News:Leading Children’s Sun Protection Swimwear Company Platypus Australia use Skin Cancer Awareness Month to Help Educate Parents 2 Health News:Leading Children’s Sun Protection Swimwear Company Platypus Australia use Skin Cancer Awareness Month to Help Educate Parents 3

[0] Mileageads Ad Network Now Invites Bloggers and Business Owners in Mesothelioma Sector to Advertise on Their Ad Network [0] ER docs are key to reducing health care costs [0] Jimmy Buffett Las Vegas Tickets: Jimmy Buffett Tickets in Vegas at the MGM Grand on Oct. 19 and Oct. 26 Go on Public Sale Monday, May 20 at 10:00 a.m. Local Time [0] The "17 Cheat Foods That Burn Fat" Review and Diet Plan Secrets Revealed by Daily Gossip [0] Leading Children’s Sun Protection Swimwear Company Platypus Australia use Skin Cancer Awareness Month to Help Educate Parents

... Multimedia Effort to Launch Contact Lenses in Puerto ... ... 28 Johnson & Johnson Vision,Care, today announced a multi-faceted marketing campaign ... Contact Lenses in Puerto Rico, the Caribbean and Central,America., Following its ...

... in Heavy Rotation Through Primary, OAKLAND, Calif., ... crucial,primary vote Tuesday, the National Nurses Organizing Committee/California,Nurses ... Ohio with,an emphatic message to the presidential candidates ... healthcare reform., The 60-second radio ad is ...

... lupus erythematosus (SLE), commonly known as lupus, can affect ... skin, kidneys, heart, nervous system, and brain. Along ... and skin rashes, neurologic and psychiatric events often accompany ... 37 and 95 percent of SLE patients experience signs ...

... Kimmel Cancer Center in Philadelphia have shown that they ... laboratory and in experimental animal models by blocking a ... The work proves that the protein, Stat5, is both ... is a viable target for drug therapy. , The ...

... Year 2007 Highlights, - Revenue for the fourth quarter was $469.5 ... year was $1.8 billion, a 40% ... - Average occupancy for the fourth quarter was 90.6% and for the full ... from 90.4% for the full year of 2006., - Same store Facility ...

... 27 Actavis Group, the,international generic pharmaceuticals company, ... U.S. Food & Drug Administration., The four ... generic equivalent of,Bontril(R) tablets by Valeant Pharmaceuticals, are ... sales of Phendimetrazine tartrate tablets,had annual sales of ...

Eyes on Puerto Rico: Johnson & Johnson Markets New Contact Lenses Directly to Consumers Nurses Launch Major Ohio Radio Ad Campaign Telling Candidates: Stop Selling Insurance and Back Real Reform Autoantibodies and neuropsychiatric events in lupus Blocking protein kills prostate cancer cells, inhibits tumor growth, Jefferson scientists find Brookdale Announces Fourth Quarter and Full Year 2007 Results Actavis Extends Portfolio With Four New Products in the U.S.

(Date:5/17/2013)... May 17, 2013 Orexigen® Therapeutics, Inc. (Nasdaq: ... overview at the UBS Global Healthcare Conference in ... May 22 nd at 11 a.m. Eastern Time. To ... presentation, please visit the Investor Relations section of the Company,s ... available for 14 days after the event. About ...

(Date:5/17/2013)... 17, 2013 Shareholder rights attorneys at Robbins ... Inc. (NASDAQGS: AVEO) securities has filed a complaint in ... Massachusetts . The complaint alleges that Aveo ... Act of 1934 (the "Exchange Act") between January 3, ... (Logo: http://photos.prnewswire.com/prnh/20130103/MM36754LOGO ) ...

(Date:5/17/2013)... CHAMPAIGN, Ill. , May 17, 2013 Sony ... new Sony SP6800 Spectral Analyzer (SP6800). Sony will be ... 2013, which will be held at the ... San Diego, California , from May 20 - ... Sony,s second analytical system, incorporating commercial audio-visual technologies into ...

Breaking Medicine Technology:Aveo Pharmaceuticals, Inc. Sued by Investor 2 Aveo Pharmaceuticals, Inc. Sued by Investor 3 Sony Biotechnology Inc.'s New Technology for Science Provides Researchers Results in Color 2

[0] Orexigen Therapeutics to Present at the UBS Global Healthcare Conference [0] Aveo Pharmaceuticals, Inc. Sued by Investor [0] Sony Biotechnology Inc.'s New Technology for Science Provides Researchers Results in Color

... and LOS ANGELES, Oct. 14 /PRNewswire-Asia/ -- China,Yongxin Pharmaceuticals, ... Company"), a leading manufacturer, distributor and,retailer of pharmaceuticals in ... second quarter of 2009 which ended June 30,2009. , ... of 2009 were essentially flat at,approximately $14.6 million compared ...

... VSCP ), a leading provider of quantitative imaging for ... chief business and financial officer, will be presenting a corporate ... Forum in San Francisco, California. Ms. Henderson is scheduled to ... 2009 at the Palace Hotel, San Francisco. , A live ...

China Yongxin Pharmaceuticals Inc. Announces Second Quarter 2009 Financial Results VirtualScopics to Present at the 8th Annual Bio Investor Forum

When You Need Optimal Patient Comfort with Minimal Weight at a Nonunion Site...Demand The OrthoPak Noninvasive Bone Growth Stimulator. , ,Most Appropriate for the Proximal Femur, Metatarsal/Tar...

... Pulsed ElectroMagnetic Field (PEMF) bone growth stimulation ... option for long bone and small bone ... cast, orthopedic brace, or clothing without lessening ... in one compact, lightweight unit including success ...

Our products, with carefully researched design features, are tailored to making arthroscopic and ligament reconstructive surgery more reproducible, easier, quicker and safer....

... Cannulated Interference Screws. Optimal ... and graft selection options. ... without deformation, and chamfered ... threaded atraumatic tissue fixation. ...

Medicine Products:

BioElectron Orthopak Physio-Stim Bone Growth Stimulator Interference Screws ABSOLUTE Absorbable Cannulated Interference Screws