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:10/20/2014)... Columbus, OH (PRWEB) October 20, 2014 National ... Ohio Chapter of the American Academy of Pediatrics (Ohio AAP, ... Administration (NHTSA) in encouraging parents of teen drivers to talk ... hit the road. , Motor vehicle crashes are the leading ... 2,055 teen drivers involved in fatal crashes, and 859 (42%) ...
(Date:10/20/2014)... It’s hard to imagine what it’s like to live without ... world, it’s a reality. And while new shoes are considered ... walk barefoot on rocky terrain or sewage-lined streets just to ... , Buckner International's Shoes for Orphan Souls ... to encourage support for Air1 and while also providing new ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Do you ... interventions? Here comes a wonderful app Metassessor for teachers, ... development company helped its client “Intervention Development LLC” ... The app is designed for iOS 4.3 or later ... This app is optimized for iPhone 5. It is ...
(Date:10/19/2014)... October 20, 2014 Recently, BambooIndustry.com, one ... unveiled its new range of bamboo deckings . ... these natural items; they are now available at deeply ... people, it is hard to overstate the significance of ... attention to online services. The company’s workers are striving ...
(Date:10/19/2014)... (PRWEB) October 20, 2014 Having been working ... a good knowledge of customer needs. According to James, one ... covered with dazzling sequins, or with high-low skirts that add ... a huge demand. Recently, LunaDress has unveiled its new selection ... of fact, the company’s brand new items are available in ...
Breaking Medicine News(10 mins):Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 3Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 3Health News:High Quality Bamboo Deckings, New Items Unveiled By BambooIndustry.com 2Health News:2014 Long Prom Dresses From LunaDress Now Available In Over 20 Popular Designs 2
... that the public will use performance data to choose their ... a paper published on bmj.com today, two experts ... choice is not at present a strong lever for change, ... improved to optimise its effect. Research conducted over the ...
... HealthDay Reporter , WEDNESDAY, Nov. 24 (HealthDay News) -- ... of heartburn drugs while they were pregnant did not ... a large Danish study finds. This class of ... as Prilosec (omeprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). All ...
... 24 (HealthDay News) -- Excessive alcohol consumption -- a common ... injury and death, warns the American College of Emergency Physicians ... when they get together with family and friends. "Very ... suffer the loss of a loved one because of an ...
... , WEDNESDAY, Nov. 24 (HealthDay News) -- Parents ... if they,re traveling during the holiday season, an expert warns. ... you can,t plan for everything, being prepared will help keep ... Cahill, an associate professor of pediatrics at Loyola University Chicago ...
... WEDNESDAY, Nov. 24 (HealthDay News) -- A study conducted ... for blacks than it is for whites. In fact, ... one-fifth higher than it is for whites in that state. ... on Smoking and Health at the U.S. Centers for Disease ...
... Americans get ready to travel to holiday gatherings with family and ... them are reminded that there are some things you need to ... pack a copy of all vaccination records so that you can ... those records if you board your pet while going on an ...
Cached Medicine News:Health News:Experts question whether patients will use performance data to choose their care 2Health News:No Link Between Heartburn Drugs and Birth Defects: Study 2Health News:No Link Between Heartburn Drugs and Birth Defects: Study 3Health News:Holiday Drinking Can Kill, Experts Warn 2Health News:Preparation Can Help Kids With Nut Allergies Travel Safely 2Health News:Black Smokers May Face Higher Death Risk Than Whites: CDC 2
(Date:10/17/2014)... , October 17, 2014 ... Markets ( http://www.researchandmarkets.com/research/rxznjk/micro_market ) has announced the ... : North American Automated External Defibrillators ... ,     (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ,The report North ... analyzes the market of devices based ...
(Date:10/17/2014)... , Oct. 17, 2014  Talyst, a market ... 2014 LeadingAge Annual Meeting in Nashville, TN. ... System, the market leading solution for onsite, remote medication ... term care facilities to safely and securely dispense medication ... to first dose, helps ensure that the correct medication ...
(Date:10/17/2014)... Oct. 17, 2014  China Biologic Products, Inc. ... leading fully integrated plasma-based biopharmaceutical company in ... Company has received approval from the China Food ... of human prothrombin complex concentrate ("PCC") at its ... new coagulation factor production facility for Good Manufacturing ...
Breaking Medicine Technology:Micro Market Monitor : North American Automated External Defibrillators (AED) Market 2Talyst Exhibits at LeadingAge Annual Meeting 2China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility 2China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility 3
... 2011 Endologix, Inc. (Nasdaq: ELGX ), ... today the presentation of the initial clinical results from ... of Endovascular Specialists) annual meeting in Scottsdale, Arizona. Among ... trial, technical success rates of 97% (access) and 100% ...
... The Florida Society of Pain Management Providers ( ... www.fapmmed.net ) and The American Academy of Pain Management ... Attorney General Pam Bondi for their support of the ... the recently announced attempt to repeal the program. ...
Cached Medicine Technology:Endologix Announces Presentation of Favorable Initial PEVAR Trial Results 2Endologix Announces Presentation of Favorable Initial PEVAR Trial Results 3Florida Pain Clinic Organizations Applaud FL Senate President Haridopolos and Attorney General Bondi 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
... 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 ...
... 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 ...
Medicine Products: