Navigation Links
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

Page: 1 2 3 4

Related medicine news :

1. Transcept Pharmaceuticals to Present at Needham Life Sciences Conference on June 10, 2009
2. Transcept Pharmaceuticals Presents Data from Studies of Two Product Candidates at Annual Meeting of the American Psychiatric Association
3. Transcept Pharmaceuticals Reports First Quarter 2009 Financial Results
4. Transcept Pharmaceuticals Appoints Joseph T. Kennedy as General Counsel
5. Transcept Pharmaceuticals Reports Fourth Quarter and Year End 2008 Financial Results
6. Transcept Pharmaceuticals to Report Fourth Quarter 2008 Results
7. Transcept Pharmaceuticals to Present at Two Upcoming Conferences
8. Transcept Pharmaceuticals, Inc. Completes Merger with Novacea, Inc.
9. Transcept Pharmaceuticals to Participate on Drug Delivery Investor Panel
10. Transcept Pharmaceuticals, Inc. to Present at the 20th Annual Piper Jaffray Health Care Conference
11. Transcept Pharmaceuticals to Present at the Jefferies 2nd Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2015)... Medelis, Inc., a specialty oncology CRO ... in the role of president. , “ Bill Taaffe ... industry,” said Larry Flanagan, Medelis’ CEO and co-founder. “He will ... next phase of growth.” , Taaffe joined ICON’s U.S. ... employees to over 4,500 employees, achieving 12 consecutive years of ...
(Date:5/28/2015)... May 28, 2015 ISMETT , a ... Italy, boosted the Sicilian economy by €132.5 million in expenditure ... benefit of more than €73 million by retaining patients who ... to a new study by the Battelle Memorial Institute. At ... research, training and advanced health care management that is transforming ...
(Date:5/28/2015)... Trends Investing ” was featured on NewsWatch as part of ... medium, and large businesses making an impact in their industry. ... the business review and shared with viewers how this website ... money. , The idea, “let your money work for you” ... how to succeed are two different things. So if ...
(Date:5/28/2015)... May 28, 2015 Senior Housing Assistance ... Lou Piniella, who managed the Seattle Mariners team that ... will appear in television and digital advertising for SHAG ... apartment communities, including several new communities slated to open ... Bothell, Lynnwood, Mountlake Terrace, Tukwila, and University Place. , ...
(Date:5/28/2015)... (PRWEB) May 28, 2015 Ticket Down is ... soccer match between Mexico and Argentina in early ... the world will compete on the pitch at AT&T Stadium ... another in an international friendly on Tuesday, September 8th at ... talented nations in the world including some of the most ...
Breaking Medicine News(10 mins):Health News:Bill Taaffe, Former President and CEO of ICON Clinical Research-US, Joins Medelis, a Specialty Oncology CRO, in the Role of President 2Health News:UPMC-Managed Transplant Hospital Drives Major Economic Benefits for Sicily, Study Finds 2Health News:UPMC-Managed Transplant Hospital Drives Major Economic Benefits for Sicily, Study Finds 3Health News:An Application to Learn Where to Invest Money was Featured on NewsWatch Television 2Health News:SHAG Announces New Spokesperson: Lou Piniella 2Health News:Mexico vs. Argentina Tickets at AT&T Stadium: Ticket Down Slashes Ticket Prices on Argentina vs. Mexico Presale Tickets at AT&T Stadium for 9/8/15 Friendly Match 2Health News:Mexico vs. Argentina Tickets at AT&T Stadium: Ticket Down Slashes Ticket Prices on Argentina vs. Mexico Presale Tickets at AT&T Stadium for 9/8/15 Friendly Match 3
... 11 Oridion,Systems, Ltd. - (SWX: ORIDN) ... improving patient safety. This new launch ... of,Anesthesiologists in San Francisco, CA. Smart ... its new SARA(TM) software for improved alarm ...
... the first,time in Pennsylvania, Level III Trauma Center accreditation status ... 1, 2007 through,October 31, 2008:, ... Good Samaritan Regional Medical Center, Pottsville, PA, ... by the Emergency Medical Services Act (Act 1985-45).,The PTSF is ...
... * concentrated Tylenol(R) Infants, Drops Plus Cold and cough ... * PediaCare(R) Infant Drops products, ... of McNeil-PPC, Inc., announced today that the,company is voluntarily withdrawing certain ... these medicines are generally,recognized as safe and effective. While most parents ...
... scrapbooking service to help ... MIAMI, Oct. 11 Scrapblog, Inc., the first web-based,service ... partnering with the March of Dimes, a national not-for-profit health,agency ... ,Every,Baby Has a Story, campaign. ,Every Baby Has a ...
... retirees will benefit, SACRAMENTO, Calif., Oct. 10 ... California State University (CSU) retirees to,participate in a ... very grateful that the Legislature and governor have ... all state retirees," said,Barbara LaPlante, President of CSEA ...
... Molina Healthcare Inc. (NYSE: MOH ),will replace Keystone Automotive ... after the close of trading on Friday, October 12. Keystone ... LKQX ) in,a deal that is expected to close ... Poor,s will monitor this transaction, and post any relevant,updates on ...
Cached Medicine News:Health News:Oridion Introduces New Smart Capnography System for Improved Patient Safety 2Health News:Oridion Introduces New Smart Capnography System for Improved Patient Safety 3Health News:Oridion Introduces New Smart Capnography System for Improved Patient Safety 4Health News:First Level III Trauma Center Accredited in Pennsylvania 2Health News:McNeil Consumer Healthcare is Voluntarily Withdrawing Infants' Cough and Cold Products: 2Health News:McNeil Consumer Healthcare is Voluntarily Withdrawing Infants' Cough and Cold Products: 3Health News:Scrapblog(TM) Teams with March of Dimes to Tell Every Baby's Story 2Health News:Scrapblog(TM) Teams with March of Dimes to Tell Every Baby's Story 3Health News:Governor Signs Bill Providing Vision Care Program for State University Retirees 2Health News:Standard & Poor's Announces Change to U.S. Index 2
(Date:5/28/2015)... CHICAGO , May 28, 2015  It takes ... gift to help break the cycle of hunger and ... May 28, by announcing that its recent donation to ... Africa Dairy Development Project (EADD) in Tanzania ... Heifer,s EADD Project, and perhaps changing their lives forever. ...
(Date:5/28/2015)... 28, 2015 Lungpacer Medical, Inc., a ... system announced today that it will be presenting ... Thursday, June 4, 2015 in New York City.  ... Eastern Time.   About Lungpacer Medical, ... stage medical device company pioneering the development of ...
(Date:5/28/2015)... , May 28, 2015  Oticon, Inc. is ... People Awards. The national awards program, now in its ... with hearing loss who demonstrate that hearing loss does ... excel. People with any degree of ... are eligible. Winners in four categories earn cash prizes, ...
Breaking Medicine Technology:AbelsonTaylor Honors World Hunger Day 22015 Oticon Focus on People Awards Seek Outstanding People with Hearing Loss For National Recognition and Prizes 2
... 2012  IMCAS -- Merz Aesthetics today releases further intriguing insights uncovered ... our out of five surveyed European women think that ... dermal fillers, botulinum toxins, and laser treatments to maintain their ... for the super-rich or Hollywood elite, two thirds of the ...
... (NASDAQ: MASI ) announced today that it will ... ended December 31, 2011, after the market closes on February 14, ... 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by ... Raad, Executive Vice President and Chief Financial Officer. A ...
Cached Medicine Technology:The Changing Face of Beauty 2The Changing Face of Beauty 3The Changing Face of Beauty 4The Changing Face of Beauty 5Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012 2Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012 3
... Multidrop DW is a high-speed automated dispenser for ... 96-well plates. Designed for accuracy and precision, the ... It covers a volume range of 20-995 l. ... high-precision peristaltic pump to dispense directly from single ...
... Multidrop 384 offers lower consumption of ... screening applications. The Multidrop 384 is ... screening and microvolume dispensing into 384- ... outstanding flexibility. It can easily switch ...
RIA kit for the determination of autoantibodies to the muscle-specific receptor tyrosine kinase....
... 9700 Interchangeable sample block modules for ... high speed 5C/sec average heating/cooling rate of block ... and cycle sequencing Gold-plated silver block provides ... PCR System 9700 can now be used with ...
Medicine Products: