Navigation Links
Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application
Date:10/28/2009

hese forward-looking statements, and claims the protection of the safe harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, the sufficiency of data submitted and data that may be generated and submitted in support of the NDA for Intermezzo® to receive FDA approval for its intended indication, including whether or not additional clinical or non-clinical studies will be required to obtain FDA approval; the timing and potential outcome of regulatory decisions by the FDA on the NDA for Intermezzo®; the commitment of Transcept to make Intermezzo® available to insomnia patients; and the potential for Intermezzo® to be the first prescription sleep aid specifically approved by the FDA for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, whether additional data exists or can be generated from existing or new clinical studies to demonstrate sufficiently to the FDA that Intermezzo® would not present an unacceptable risk of residual effects, including residual effects that impair next day driving ability; whether Transcept can sufficiently demonstrate to the FDA that it can reduce dosing errors in the middle of the night or that dosing errors will not lead to unacceptable next day residual effects; FDA decisions on the sufficiency of other data submitted in support of the Intermezzo® NDA to receive approval for its intended indication and any further delays in, and the final form of, any FDA approval of Intermezzo®; a decision by Purdue to terminate the Collaboration Agreement, even if the Intermezzo® NDA is approved; obtaining and maintaining Hatch-Waxman exclusivity for Intermezzo®
'/>"/>
SOURCE Transcept Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Transcept Pharmaceuticals to Report First Quarter 2009 Results
2. Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
3. Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
4. Cadence Pharmaceuticals CEO Ted Schroeder To Present at the Oppenheimer 20th Annual Healthcare Conference in New York City on November 4, 2009
5. Anadys Pharmaceuticals to Present at the Oppenheimer Healthcare Conference
6. DUSA Pharmaceuticals Surpasses One Million in Cumulative Levulan(R) Kerastick(R) Sales Units
7. Onyx Pharmaceuticals Announces Third Quarter 2009 Financial Results Teleconference and Webcast
8. Cumberland Pharmaceuticals to Announce Third Quarter 2009 Financial Results on November 10, 2009
9. Intercept Pharmaceuticals Announces Positive Phase II Results for INT-747 as a Treatment for Primary Biliary Cirrhosis
10. Bellicum Pharmaceuticals Announces $4.5 Million in New Funding
11. BioMarin Acquires Huxley Pharmaceuticals, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... BERWYN, Pa. , July 25, 2014  AMETEK, ... appointment of Kurtis L. Goos as Vice ... Engineered Materials, Interconnects and Packaging (EMIP) Division. ... has extensive general management and business development experience, especially ... to make important contributions to the continued growth and ...
(Date:7/25/2014)... July 25, 2014  Arena Pharmaceuticals, Inc. (NASDAQ: ... corporate update and report second quarter 2014 financial results ... August 1, 2014. That same day, Arena will host ... Time (5:30 a.m. Pacific Time). The ... domestic callers and 914.495.8552 for international callers. Please specify ...
(Date:7/24/2014)...  PTC Therapeutics, Inc. (NASDAQ: PTCT ) ... conference call to report its second quarter 2014 financial ... and outlook on Thursday, August 7, 2014 at 8:30 ... The call can be accessed by dialing ... prior to the start of the call and providing ...
Breaking Medicine Technology:AMETEK Names Kurtis L. Goos, Vice President & General Manager, Engineered Medical Components 2Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Friday, August 1 2Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Friday, August 1 3
... secret is finally reaching the east coast and all points ... health and beauty boutique named Endless Youth and Life is ... supplement is helping thousands of Americans shed excess abdominal fat ... Just a few capsules per day and their stomachs are ...
... Inc. (NASDAQ: IPHS ) today announced that its ... $0.25 per share of common stock.  The dividend will be ... of the close of business on October 14, 2011. ... American producer of specialty phosphate products, offering performance-critical ingredients with ...
Cached Medicine Technology:Beverly Hills Secret Now Helping People Across The Country 2
(Date:7/25/2014)... As reported by the Statesman Journal in ... (7/20), police in Salem, MA as well as several ... recent heroin epidemic that has taken many lives during the ... overdose case in which police were able to make two ... By pretending to be the victim and claiming to want ...
(Date:7/25/2014)... NY (PRWEB) July 25, 2014 ... prices across the board for the Guinness International Champions ... and Olympiacos FC at Soldier Field on Sunday, ... offering their customer appreciation promo/coupon/offer code SOCCER-2014 for added ... amazing year for diehard soccer fans in North America. ...
(Date:7/25/2014)... -- Seniors are more easily distracted during thinking and ... "Almost any type of memory test administered reveals ... on," study co-author Randi Martin, professor of psychology at ... However, Martin said, this study shows that "environmental interference" ... compared with younger adults. The study included 60 ...
(Date:7/25/2014)... UT (PRWEB) July 25, 2014 ... surfaces for the recent Nike National Invitational Tournament ... current United States Junior National Tournament (USJN) ... 25. , The flooring for these prestigious national tournaments ... than 300,000 square feet of playing surface at McCormick ...
(Date:7/25/2014)... Reproductive Science Center (RSC) of New England ... Lead Physician at RSC Rhode Island, received the distinguished ... fertility care and community outreach issued by Providence Business ... Awards ceremony held July 24th at Salve Regina University ... regarded, emerging leaders in their field were recognized by ...
Breaking Medicine News(10 mins):Health News:Multiple States Crack Down on Heroin Epidemic 2Health News:Liverpool FC vs. Olympiacos FC Tickets Soldier Field: Ticket Down Slashes Ticket Prices for Guinness International Champions Cup in Chicago on Sunday, July 27th 2Health News:Distractions Seem More Troublesome With Age 2Health News:Sport Court Provides All Sports Flooring for Basketball Events in Chicago and Washington D.C. 2Health News:Dr. Kerri Luzzo of the Reproductive Science Center of Providence Receives “40 Under Forty Award" for Outstanding Professional Accomplishments and Community Outreach 2
... the way the industry outsources its services by providing a backroom ... professionals and resellers. , ... Bohemia, NY (Vocus) April, ... specialized expertise and only generates a few cents in revenue? This ...
... over-the-counter melatonin reduces time to slumber , , FRIDAY, April ... treat sleep problems in children with autism, a small ... aged 2 to 15 years, with autism spectrum disorder, ... randomly selected to take melatonin or a placebo for ...
... MIAMI, April 17 Not since the United States ... such significant hardships to their health and well-being across ... wellness. Losing jobs at a rapid pace, people are ... of identity, security and status. Yet Miami,s St. ...
... events have led people to re-examine their lifestyles and ... that it is time to get to the basics ... to start their families now, instead of waiting for ... a growing number of couples who are consulting fertility ...
... DEBRECEN, Hungary, April 17 Bertalan Mesko, medical blogger ... with his readers. EchoJournal, a video site designed to ... by the editorial team of one of the most ... features familiar to users of other video sharing sites, ...
... experts say results from the small study are no reason ... -- Lower hormone levels in women who exercise regularly and ... a new study suggests. , But the muscle-mass differences between ... did not affect performance. , At this point, ...
Cached Medicine News:Health News:Penny Imaging Exchange, Inc. Outlines the Trend & Economics of Scanning Microfilm 2Health News:Penny Imaging Exchange, Inc. Outlines the Trend & Economics of Scanning Microfilm 3Health News:Melatonin May Ease Sleep Problems in Autistic Children 2Health News:Good News for Tough Times: Small, Private University Responds to Today's Economic Challenges 2Health News:Family Cocooning in the Face of Recession Leads to Expanded Business for Bay Area Fertility Doctor - Dr. Danielle Lane 2Health News:The Pill May Limit Muscle Gains in Women 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: