Navigation Links
Cipher provides CIP-TRAMADOL ER regulatory update
Date:2/11/2008

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Feb. 11 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that the U.S. Food and Drug Administration (FDA) has suggested an additional statistical sensitivity analysis of existing clinical data on CIP-TRAMADOL ER, Cipher's extended-release tramadol formulation, as a means to potentially satisfy the requirements for approval.

In December 2007, Cipher appealed the decision in the Agency's May 2007 Approvable Letter through the Formal Dispute Resolution process. On February 1, 2008, the Company announced that it received a written response from the FDA regarding its first stage of appeal. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the Division's approvable action. In a subsequent discussion with Cipher, the Agency informed Cipher of the new analysis as an alternative to continuing the Formal Dispute Resolution process.

As a consequence, Cipher is suspending its appeal at this time and expects to meet with the Division in the near future to obtain further details on the additional analysis.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Fo
'/>"/>

SOURCE Cipher Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Cipher appoints Stefan Aigner to board of directors
2. Cipher Appeals FDAs Decision On CIP-TRAMADOL ER
3. Cipher reports third quarter fiscal 2007 results
4. Legal Employer Provides Companies with Competitive Edge by Assuring Consumers that Workers are Legally Documented
5. Laser Energetics Provides Joint Venture Update to Shareholders
6. ATS Medical Provides Update on First Generation Tissue Valve Approval
7. OxySure(R) Systems, Inc. Named to 2008 Worlds Best Technologies (WBT) List For its Unique, Safe and Easy to Use Portable Emergency Oxygen Generator, Which Provides Medical Oxygen Without the Need for Compressed Tanks
8. GfK Asia Provides New View on the Optics Industry
9. Young Innovations, Inc. Provides Fourth Quarter Conference Call Details
10. NutraCea Provides Update on Domestic Operations
11. Mylan Provides Update Relating to Ongoing Lorazepam and Clorazepate Litigation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... 31, 2014 Quincy Bioscience, a fast-growing ... health supplement Prevagen®, releases the second edition of the ... for Making Memories: Birth of a Grandchild. , ... exceptional memory-making tips and ideas for grandparents to utilize ... a grandchild. Each concept published in the e-book is ...
(Date:7/31/2014)... FL. (PRWEB) July 31, 2014 ... USARAD Holdings Inc. a leading US Joint Commission ... the most innovative and technologically advanced consumer storage ... The teleradiology leader is providing valued members the ... enhancing the extraordinary services already offered by SecondOpinions.com®. ...
(Date:7/31/2014)... During an annual summer didactic and live ... Dallas plastic surgeon and a member of the ... demonstration of facial anatomy and key advances in facial ... Summer Meeting of the Cosmetic Bootcamp included lectures, anatomical ... key principles in modern facial surgery. , One of ...
(Date:7/31/2014)... July 31, 2014 Body Well Therapy ... insurance patients seeking massage therapy in all 44 states ... option for Licensed Massage Therapists who do not otherwise ... to BWT. Should a patient request a specific qualified ... can then contract the therapist to provide therapeutic massage ...
(Date:7/31/2014)... 2014 Cheerag D. Upadhyaya ... neurosurgeons at the Saint Luke’s Marion Bloch Neuroscience ... director of spine surgery. He comes to SLMBNI from ... Upadhyaya has been recognized for his excellent work, research ... His addition to the Saint Luke’s Marion Bloch Neuroscience ...
Breaking Medicine News(10 mins):Health News:Quincy Bioscience Launches the Second E-Book of the Making Memories Series 2Health News:SECONDOPINIONS.COM® Introduces Innovative Cloud-Based Medical Imaging Exchange Service for Easy Upload, Access and Sharing Anytime/Anywhere 2Health News:SECONDOPINIONS.COM® Introduces Innovative Cloud-Based Medical Imaging Exchange Service for Easy Upload, Access and Sharing Anytime/Anywhere 3Health News:Dr. Rod J. Rohrich Demonstrates Advances in Facial Surgery at Annual Cosmetic Surgery Seminar 2Health News:Dr. Rod J. Rohrich Demonstrates Advances in Facial Surgery at Annual Cosmetic Surgery Seminar 3Health News:Body Well Therapy Invites Massage Therapists Nationwide to "Bring Your Own Insurance Clients" 2Health News:Body Well Therapy Invites Massage Therapists Nationwide to "Bring Your Own Insurance Clients" 3Health News:Saint Luke’s Marion Bloch Neuroscience Institute welcomes Cheerag D. Upadhyaya, M.D., as director of Spine Program 2Health News:Saint Luke’s Marion Bloch Neuroscience Institute welcomes Cheerag D. Upadhyaya, M.D., as director of Spine Program 3Health News:Saint Luke’s Marion Bloch Neuroscience Institute welcomes Cheerag D. Upadhyaya, M.D., as director of Spine Program 4
... A new study finds that breast cancer patients who ... effectively, and altering health behaviors live longer than patients ... the December 15, 2008 issue of CANCER, ... study indicates that reducing the stress that can accompany ...
... that DFMO may influence the extent of Barrett,s dysplasia, ... this agent in a larger number of patients is ... and oncology at the Mayo Clinic, Rochester, MN. , ... for Cancer Research,s Seventh Annual International Conference on Frontiers ...
... at The Feinstein Institute for Medical Research have figured out why ... levels that accumulate in the brains of Alzheimer’s patients. , ... ... The Feinstein Institute for Medical Research have figured out why a ...
... known to inhibit the growth of ovarian cancer works in ... die, researchers at The University of Texas M. D. Anderson ... Cancer Research . , The research team also found that ... indicator of a woman,s prospects for surviving ovarian cancer, said ...
... pathway not previously linked to breast cancer is driving ... and disproportionately over-represented in African American women. , The ... represents a class of genes called proteasome targeting complexes. ... tumor suppressor gene p27 by making a new type ...
... effective, say Children,s Hospital of Pittsburgh reseachers , , ... of bone marrow transplantation is the only safe and ... Hospital of Pittsburgh report. , Traditional bone marrow transplants ... in order to destroy a recipient,s bone marrow so ...
Cached Medicine News:Health News:Psychological interventions associated with breast cancer survival 2Health News:DFMO may affect Barrett's esophagus 2Health News:Substance in Red Grapes and Wine Key to Alzheimer's Disease 2Health News:Protein compels ovarian cancer cells to cannibalize themselves 2Health News:UCLA scientists find cell pathway driving a deadly sub-type of breast cancer 2Health News:UCLA scientists find cell pathway driving a deadly sub-type of breast cancer 3Health News:Unique Bone Marrow Transplant Said to Cure Sickle Cell 2
(Date:7/30/2014)... , July 30, 2014 In conjunction ... quarter 2014 financial results press release, you are invited ... broadcast live over the internet on Thursday, August 7, ... Time). A live audio webcast of the ... http://www.durect.com and clicking "Investor Relations."  If you ...
(Date:7/30/2014)... ALEXANDRIA, Va. , July 30, 2014 /PRNewswire-USNewswire/ ... of Managed Care Pharmacy (AMCP) last evening expressed ... developed by the Joint Commission of Pharmacy Practitioners ... other member organizations over a two-year period to ... process for pharmacists.  "Pharmacists are ...
(Date:7/30/2014)... 30, 2014 Research and Markets has announced ... Forecasts to 2019" report to their offering. ... to grow at a lower CAGR in developed countries; however, it ... China , India , and ... The growth of the hematology analyzers and reagents market is ...
Breaking Medicine Technology:DURECT Corporation Invites You to Join its Second Quarter 2014 Earnings Conference Call 2AMCP Endorses JCPP "Pharmacists' Patient Care Process" 2Hematology Analyzers & Reagents Market - Forecasts to 2019 2
... PAREXEL International Corporation (Nasdaq: PRXL ... the Company has won the 2010 Scrip Award ... presented to PAREXEL at the sixth annual ... a leading news, data, and information service for the global ...
... 14, 2010 WHAT:You are invited to demo a new ... Panasonic Healthcare Co., Ltd. Currently applying for FDA clearance, ... engine, offering real-time detection of the thickness of the ... is the first comprehensive solution for screening and ...
Cached Medicine Technology:PAREXEL Wins Clinical Research Team of the Year Scrip Award 2PAREXEL Wins Clinical Research Team of the Year Scrip Award 3PAREXEL Wins Clinical Research Team of the Year Scrip Award 4PAREXEL Wins Clinical Research Team of the Year Scrip Award 5Panasonic Unveils CardioHealth® Station - First Comprehensive Screening Solution to Detect Heart Disease in Asymptomatic Population 2
Blunt tipped forceps with small, slightly rounded tips angled perpendicular to the shaft. For grasping peripheral membranes....
... features an advanced design, solid state oscillator ... as many years of clinical experience, has ... for the placement of discrete burns on ... the maximum effect at the target tissue ...
Anterior chamber protein cell meter. Laser flare meter and cell-counting functions are included in this cell meter, with dramatically enhanced measurement of cell volume....
... Rare Earth Intraocular Magnet is especially designed ... foreign bodies. The precise, sleek design of ... observed with electromagnetic devises. Due to its ... the possibility of secondary foreign body incarceration. ...
Medicine Products: