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:4/24/2015)...  Bayer Corporation hosted its annual "Take Your Child to ... US headquarters.  This is Bayer,s second "Take Your Child To ... campus, and Thursday,s event welcomed 230 children ready to ... Fortunately, for the kids, this was not just ... is "Science For A Better Life," Bayer made sure that ...
(Date:4/24/2015)... CHAPEL HILL, N.C. , April 24, 2015 ... marketplace, organizations are establishing employee groups around the ... workforce and round-the-clock business hours. While there are ... becoming global, leaders must examine which best practices ... global operational excellence. According to ...
(Date:4/24/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/pmbmv2/global_biobanking ) has ... 2015-2019" report to their offering. The ... a CAGR of 7.07% over the period 2014-2019 ... two segments: Equipment and Consumables. This report covers the ... Biobanking market for the period 2015-2019. ...
Breaking Medicine Technology:Bayer Hosts "Take Your Child to Work Day" 2Bayer Hosts "Take Your Child to Work Day" 3Bayer Hosts "Take Your Child to Work Day" 4Work Around the Clock: Building Effective Global Capabilities 2Global Biobanking Market Report 2015-2019 - Increase in Strategic Collaborations with Beckman Coulter, Tecan & Thermo Fischer Scientific Dominating 2
... ANGELES, Oct. 13, 2011 IVD Technology ... in vitro diagnostics technologies including research, development, and manufacturing, ... most significant emerging trend in the industry ... (CONTACT:   http://photos.prnewswire.com/prnh/20101214/LA16070LOGO ) The ...
... Oct. 13, 2011 PharmAthene, Inc. (NYSE Amex: ... brief in response to SIGA Technologies, motion for reargument.  On ... Chancery had issued a ruling in its litigation against SIGA ... years from all sales of ST-246 and related products after ...
Cached Medicine Technology:Distinguished Speaker Dr. Elizabeth Mansfield Joins IVD Technology for Upcoming Webcast: The Regulation of Companion Diagnostics: Current Status and Updates 2Distinguished Speaker Dr. Elizabeth Mansfield Joins IVD Technology for Upcoming Webcast: The Regulation of Companion Diagnostics: Current Status and Updates 3PharmAthene Submits Legal Brief in Response to SIGA Technologies' Motion for Reargument 2PharmAthene Submits Legal Brief in Response to SIGA Technologies' Motion for Reargument 3
(Date:4/25/2015)... New Jersey (PRWEB) April 25, 2015 ... people aged twelve and above needed treatment for an ... according to the Substance Abuse and Mental Health Services ... September 2011). Beyond these alarming numbers are harrowing stories ... by substance abuse . David H. Kerr ...
(Date:4/25/2015)... York, NY (PRWEB) April 25, 2015 By ... technology and data for the enterprise relying on their judgement ... running smoothly. But according to an article published ... can many times actually be doing a disservice to their ... i’s are dotted and t’s are crossed when it comes ...
(Date:4/25/2015)... Illinois (PRWEB) April 25, 2015 ... enrichment and wellness, management and operations, and sales ... Meeting and Exhibition scheduled to be held from ... , LeadingAge Illinois is the largest eldercare association ... providers of services for older adults, including senior ...
(Date:4/25/2015)... Sports controversies continue to revolve around issues of ... the case with the Miami Dolphins and Richie Incognito, or off ... Ray Rice domestic abuse case. In a recent episode of ... the implications of locker room culture on teams. He examines what ... should do to improve the locker room as a work place. ...
(Date:4/24/2015)... CA (PRWEB) April 24, 2015 Bird B ... and residential applications now offers a complete line of bird ... to poultry farms. , New Flu Strains Threaten Pacific, Central ... 2015 USDA post , a number of highly pathogenic ... paths. The disease is often spread when wild birds enter ...
Breaking Medicine News(10 mins):Health News:New Book Features Powerful Stories of People Who Overcame Addiction 2Health News:New Book Features Powerful Stories of People Who Overcame Addiction 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 2Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 4Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 5Health News:Gardant Management Solutions Staff Shares Operational Expertise 2Health News:David Steele Discusses Locker Room Culture on SCI TV 2Health News:David Steele Discusses Locker Room Culture on SCI TV 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 2Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 4
... Insulet Corporation,(the "Company") (Nasdaq: PODD ) announced today ... aggregate principal amount of convertible senior,notes due 2013 (the ... on Rule 144A under the Securities Act of 1933, ... an option to,purchase up to an additional $10 million ...
... regulators and ... the healthcare industry, LANSDALE, ... appeal process is a big issue facing healthcare reform, says,NAIRO ... While 44 states and Washington, D.C. have external,review laws, each ...
... Headway, LLC (Medical Headway),is pleased to announce ... MedicalHeadway.com, dedicated to arming the public with ... of medicine. The company offers,consumers free and ... cutting-edge,professional medical treatment and product information., ...
... sleep time, even within the normal range, is associated ... naps, according to a research abstract that will be ... Meeting of the Associated Professional Sleep Societies (APSS). , ... of California at San Diego, focused on 24 healthy ...
... with Down Syndrome sleep poorly, with more fragmented sleep ... to a research abstract that will be presented on ... the Associated Professional Sleep Societies (APSS). , The study, ... of Michigan, focused on 38 children with Down Syndrome, ...
... are more likely to comply with continuous positive airway ... receive their treatment from a sleep center accredited by ... a research abstract that will be presented on Tuesday ... Associated Professional Sleep Societies (APSS). , The study, authored ...
Cached Medicine News:Health News:Insulet Corporation Announces Private Offering of $65 Million of Convertible Senior Notes 2Health News:Insulet Corporation Announces Private Offering of $65 Million of Convertible Senior Notes 3Health News:NAIRO Supports Uniform Health Carrier External Review Model Act Adopted by NAIC 2Health News:A New Home for Medical Breakthroughs 2Health News:Decreased total sleep time associated with increased REM sleep during subsequent naps 2Health News:Children with Down Syndrome sleep poorly and have more fragmented sleep 2Health News:Treatment at an AASM accredited sleep center improves long-term CPAP compliance 2Health News:Treatment at an AASM accredited sleep center improves long-term CPAP compliance 3
The Guidant Fineline EZ leads with protective capsule are bipolar endocardial and designed for permanent implantation with pulse generators for cardiac pacing....
Tendril DX active-fixation leads allows for lower thresholds initially and during the lead maturation phase....
... The Model 6491 unipolar ... designed for temporary atrial and ... and after cardiac surgery. This ... downsized, making it the ideal ...
... Guidant Flextend lead is ... lead with an extendable/retractable ... helix design offers various ... permanent implantation in the ...
Medicine Products: