Navigation Links
Cipher provides regulatory update for CIP-TRAMADOL ER
Date:5/13/2008

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, May 13 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that a revised New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol. In May 2007, the Company received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER.

Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.

After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval.

Subject to FDA acceptance for filing, Cipher expects the review to be completed by October 2008. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.

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. Food and Drug Administration and Health Canada in the first quart
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. Cipher provides CIP-TRAMADOL ER regulatory update
2. Cipher appoints Stefan Aigner to board of directors
3. Cipher Appeals FDAs Decision On CIP-TRAMADOL ER
4. Cipher reports third quarter fiscal 2007 results
5. Innolife Pharma Provides Initial Update on Negotiations for Significant Product Joint Venture
6. InfuSystem Holdings Provides Business Update and Comments on First Quarter 2008 Financial Results
7. Revised AVMA Policy on Castrating and Dehorning Cattle Provides Additional Guidance for Managing Pain
8. Dubai Provides Aid for Cyclone Nargis Victims In Myanmar
9. New Evidence Provides Clinicians With Better Tools to Help Smokers Quit
10. Cholera study provides exciting new way of looking at infectious disease
11. Study finds that minimally invasive robotic bypass surgery provides health and economic benefits
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2014)... Texas (PRWEB) July 22, 2014 ... the process of deploying one of the largest physician-centric ... Network ( MHMD ) in Houston. , Created by ... M.D, the DocbookMD application will be embedded into MHMD’s ... “MHMD searched for the best technology to put this ...
(Date:7/22/2014)... (PRWEB) July 22, 2014 The market ... increase in size through 2022, according to new industry ... their appearance can benefit from a new guide published ... for women is now available at http://cherrynews.com/best-nourishing-eye-serum . ... includes instant links to many of the top skin ...
(Date:7/22/2014)... Obtaining a bachelor’s degree in nursing just ... hands-on medical experience. The School of Nursing at The ... launch of an accelerated nursing degree program that provides ... the UNCG Veterans Access Program (VAP), will start January ... some prior college credit, veterans who are RNs can ...
(Date:7/22/2014)... 22, 2014 Mona Khan Company today ... August 15th & 16th, 2014, at the Blanks Studio ... and nationally accredited Bollywood workout was launched in the ... globally appealing Bollywood culture, Bombay Jam® is a dance-based ... follow and designed with authentic Bollywood flavor. Instructor trainings ...
(Date:7/22/2014)... Beach, FL (PRWEB) July 22, 2014 ... that they are now an authorized Daikin comfort pro ... and install Daikin indoor heating and cooling system equipment. ... each one is thoroughly reviewed before being approved. , ... an innovator in the Split System Air Conditioning Market. ...
Breaking Medicine News(10 mins):Health News:Memorial Hermann Physician Network Launches Physician Mobile Communication Solution Throughout Houston 2Health News:Memorial Hermann Physician Network Launches Physician Mobile Communication Solution Throughout Houston 3Health News:Memorial Hermann Physician Network Launches Physician Mobile Communication Solution Throughout Houston 4Health News:Eye Serum Review for Women: New Guide Published Online by Top Review Website 2Health News:UNCG School of Nursing Fast-Tracks Medically Trained Veterans 2Health News:Mona Khan Company Announces Bombay Jam® Instructor Certification in Los Angeles in August 2014 2Health News:Mona Khan Company Announces Bombay Jam® Instructor Certification in Los Angeles in August 2014 3Health News:Air Conditioning & Heating Inc. Now an Authorized Daikin Comfort Pro Dealer 2
... say , MONDAY, Aug. 17 (HealthDay News) -- The first ... has been identified by U.S. researchers. , The new marker ... a T -- in a segment of DNA near the ... They found it by studying the DNA of 1,671 people ...
... First ever-activist toolkit included with an e-book using interactive iPhone technology. ... 17 Former Vermont Governor and DNC Chairman Emeritus Howard Dean ... empower grassroots activism. Dean has teamed up with Vermont-based progressive publisher ... REAL HEALTHCARE REFORM: How We Can Achieve Affordable Medical Care for ...
... , SANTA MONICA, Calif., Aug. 17 Cord Blood ... cell preservation company ( http://www.cord b lood-america.com ... to families nationwide and internationally, said today that its 10Q filing ... of 2009 shows a significantly improved balance sheet. , , ...
... , ... it’s designed to give prospective patients an idea of what the future can hold. Dr. ... plastic surgery in Dallas a view of what they think would look best for ... room. , ...
... ... ... 17, 2009 -- SuperSlow® Zone of Greater Houston has opened its doors to ... 200 provides a one-on-one efficient, effective workout in a cool (68°), studio environment with state-of-the-art ...
... ... databases enable researchers to quickly and effectively use these invaluable resources. , ... Seattle WA (PRWEB) August 17, 2009 -- ... National Cancer Institute,s Cancer Genome Anatomy Project, or CGAP. The Madeline 2.0 Pedigree Drawing ...
Cached Medicine News:Health News:Genetic Discovery May Improve Hepatitis C Treatment 2Health News:Howard Dean and Chelsea Green Publishing Utilize iPhone Technology to engage and Mobilize Americans in Healthcare Reform Debate. 2Health News:Howard Dean and Chelsea Green Publishing Utilize iPhone Technology to engage and Mobilize Americans in Healthcare Reform Debate. 3Health News:Howard Dean and Chelsea Green Publishing Utilize iPhone Technology to engage and Mobilize Americans in Healthcare Reform Debate. 4Health News:Cord Blood America Says Balance Sheet Significantly Strengthened in 2009 2Health News:Cord Blood America Says Balance Sheet Significantly Strengthened in 2009 3Health News:Dr. Jack P. Gunter Offers 3D Imaging for Dallas, Texas Plastic Surgery Patients 2Health News:Dr. Jack P. Gunter Offers 3D Imaging for Dallas, Texas Plastic Surgery Patients 3Health News:Dr. Jack P. Gunter Offers 3D Imaging for Dallas, Texas Plastic Surgery Patients 4Health News:SuperSlow Zone Opens in Bunker Hill Village 2Health News:New Online Tutorials for Madeline 2.0 and CGAP from OpenHelix 2Health News:New Online Tutorials for Madeline 2.0 and CGAP from OpenHelix 3
(Date:7/22/2014)... The number of people overdosing from opioid ... Twenty-three percent of the workforce has misused prescription painkillers, ... Health, making opioid use a serious threat to employee ... the correct dosage with a valid prescription, subtle impairment ... National Safety Council released a guide for employers, ...
(Date:7/22/2014)... , July 22, 2014  A central ... a SynCardia temporary Total Artificial Heart ... Strong Memorial Hospital with the Freedom® portable driver ... Fontana, a 64-year-old retiree from a Syracuse ... He managed the condition with medications, an implantable ...
(Date:7/22/2014)... PHILADELPHIA ,  July 22, 2014 /PRNewswire/ ... business of Thomson Reuters , the world,s ... and professionals, today announced Cortellis Clinical ... database, marked an industry-first milestone with the ... thus providing pharmaceutical professionals with greater and ...
Breaking Medicine Technology:5 things employers should know about prescription painkiller use 25 things employers should know about prescription painkiller use 3'I'm a Heartless SOB' Jokes Patient Discharged from Strong Memorial Hospital without a Human Heart 2'I'm a Heartless SOB' Jokes Patient Discharged from Strong Memorial Hospital without a Human Heart 3Thomson Reuters Cortellis Clinical Trials Intelligence Reaches Industry Milestone with 180,000 Clinical Trials 2Thomson Reuters Cortellis Clinical Trials Intelligence Reaches Industry Milestone with 180,000 Clinical Trials 3
... Sinovac Biotech Ltd. (Nasdaq: SVA ), a leading ... a letter dated January 18, 2012 from The Nasdaq Stock ... from the Company,s Board of Directors effective January 4, 2012, ... Nasdaq,s requirement that its audit committee consists of at least ...
... Ind., Jan. 24, 2012 Elanco, the animal health ... LLY ), today announced that Lilly has signed an ... company specializing in the development and commercialization of innovative ... egg, and meat production. Feed enzymes are naturally occurring ...
Cached Medicine Technology:Sinovac Receives Nasdaq Deficiency Letter Regarding Audit Committee Requirement 2Elanco Animal Health Announces Lilly's Agreement to Acquire ChemGen Corp. 2Elanco Animal Health Announces Lilly's Agreement to Acquire ChemGen Corp. 3Elanco Animal Health Announces Lilly's Agreement to Acquire ChemGen Corp. 4
... AMS 650™ and 600M™ malleable penile prostheses ... those with limited dexterity. These implants are ... patient to position them in an erect ... penis rigid enough for sexual intercourse and ...
Only Mentors reusable Alpine Leg Bag has patented Kraylex odor barrier, offset port options, and integrated loops providing total confidence and comfort....
Only Mentors reusable Alpine Leg Bag has patented Kraylex odor barrier, offset port options, and integrated loops providing total confidence and comfort....
... Freedom leg bags are part of ... versatile line of leg bags, kits, ... varied needs of our customers. These ... sizes, and constructed of 100% latex-free ...
Medicine Products: