Navigation Links
Cipher receives tentative FDA approval for extended-release tramadol capsules
Date:2/17/2009

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Feb. 17 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues related to the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized.

"Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication," said Larry Andrews, President and CEO of Cipher. "We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues."

Cipher's revised New Drug Application (NDA) for CIP-TRAMADOL ER was submitted in Q2 2008 as a 505(b)(2) application. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.
'/>"/>

SOURCE Cipher Pharmaceuticals Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Deciphering the bodys healing secrets
2. Deciphering the Language of Intoxication
3. Cipher Pharmaceuticals announces U.S. distribution and supply agreement with Ranbaxy for CIP-ISOTRETINOIN
4. Ciphers revised NDA for CIP-TRAMADOL ER accepted for review by FDA
5. Cipher provides regulatory update for CIP-TRAMADOL ER
6. Cipher provides CIP-TRAMADOL ER regulatory update
7. Cipher appoints Stefan Aigner to board of directors
8. Cipher Appeals FDAs Decision On CIP-TRAMADOL ER
9. Cipher reports third quarter fiscal 2007 results
10. China Shenghuo Receives Notice from NYSE Alternext US Regarding Listing Standards
11. A Drug That Receives Regulatory Approval for Cognitive Impairment Associated With Schizophrenia Would Earn a Higher Patient Share in the United States Than in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... ... 28, 2015 , ... Inc. magazine today ranked PREVENT Life Safety ... nation’s fastest-growing private companies. The list was unveiled online at Inc.com and is the ... last three years, PREVENT ranks higher on the list than any other company in ...
(Date:8/28/2015)... ... 28, 2015 , ... The Wilson and Juanita Mann Health ... improving a patient’s quality of life through early diagnosis and treatment. The focus ... diabetes, HIV/AIDS, STDs, and others. A Women’s, Infants & Children (WIC) clinic also ...
(Date:8/27/2015)... ... August 28, 2015 , ... This new webinar educates providers about how can ... for the next visit, their authorizations are in check, and they are current with ... Barnes, COO for Genesis Chiropractic Software, growing a practice depends on patient experience and ...
(Date:8/27/2015)... ... August 27, 2015 , ... ... cost to treat a patient with hemophilia is $175,000. Hemophilia is an inherited, ... and improving treatment. The RMHBDA exists to help raise funds for patients suffering ...
(Date:8/27/2015)... ... ... Thriveology Founders, Dr. Carly Letzt Carney and Dr. Mark Carney announced today that ... on Saturday, August 29, 2015 at the Marriott DTC, 4900 S. Syracuse Street, Denver, ... will present a two part seminar entitled, “How to Thrive as You Age & ...
Breaking Medicine News(10 mins):Health News:PREVENT Life Safety Ranks No. 3660 on the 2015 Inc. 5000 With Three-Year Sales Growth of 85% 2Health News:Health Clinic Opening and Public Art Unveiling 2Health News:A New Webinar Teaches Chiropractors How to Use Compliance Alerts to Manage Patient Relationships 2Health News:Avitus Group Encourages Business & Employee Community Involvement; Senior Level Staff Leads Way With Support of Rocky Mountain Hemophilia & Bleeding Disorders Association 2Health News:Avitus Group Encourages Business & Employee Community Involvement; Senior Level Staff Leads Way With Support of Rocky Mountain Hemophilia & Bleeding Disorders Association 3Health News:Avitus Group Encourages Business & Employee Community Involvement; Senior Level Staff Leads Way With Support of Rocky Mountain Hemophilia & Bleeding Disorders Association 4Health News:Internationally-renowned Naturopathic Doctor and Chiropractor Team up to Reveal Secrets of Avoiding Disease 2
... discovered a potent and highly-debilitating toxin in the endangered ... now prompting investigations of other marine mammals in the ... marine algae common on coral reefs, and accumulates in ... human disease caused by ciguatoxin, affects thousands of people ...
... parental abuse as a child increases a person,s chances of ... research article in the current issue of the ... (Volume 66B, Number 3). An analysis of data ... early parental emotional abuse was associated with a higher number ...
... reports, lawsuits, congressional inquiries, claims and counterclaims, the question ... people lacks a definitive answer, according to a package ... edition of Chemical & Engineering News (C&EN), ACS,s weekly ... K. Ritter explains that BPA has been used in ...
... of nuclear stress tests, More women than men are ... studies ordered by primary care physicians ... Island and The Miriam hospitals suggests a possible gender ... tests, an imaging technique that measures blood flow to ...
... new generation of highly localized wireless networks that are ... from monitoring the functioning of implants, to tracking the ... But if this emerging technological area is to mature ... definition of its scope and potential, and a clearer ...
... ADDRESS SHORTAGE IN THE ICU , Intensive care ... worsen in the future. A recent study, conducted by ... Medical Center in New York, NY, studying 590 daytime ... non-physician providers can help address these staff shortages. ...
Cached Medicine News:Health News:Seniors abused during childhood face increased risk of sleep troubles 2Health News:Rhode Island and Miriam researchers say patient gender may influence nuclear stress test referrals 2Health News:Rhode Island and Miriam researchers say patient gender may influence nuclear stress test referrals 3Health News:The future of wireless body area networks is the focus of a June 19-20 workshop at WPI 2Health News:The future of wireless body area networks is the focus of a June 19-20 workshop at WPI 3Health News:Chest journal news briefs -- June 2011 issue 2
(Date:8/27/2015)... , August 27, 2015 ... convened in Boston on July ... in an effort to more fully exploit the potential ... applied to brain diseases. "As an established ... a responsibility to assume a leadership role - in ...
(Date:8/27/2015)... SAN FRANCISCO, Calif. , Aug. 27, 2015 ... and Veracyte, Inc. (NASDAQ: VCYT ... a U.S. patient survey to advance understanding of ... including idiopathic pulmonary fibrosis (IPF). The Interstitial Lung ... steps and time required for patients to receive ...
(Date:8/27/2015)... and MENLO PARK, Calif. ... (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical ... cancer therapies, today announced that it will release its ... 30, 2015 on Friday, September 4, 2015. ... conference call and live webcast for investors, analysts and ...
Breaking Medicine Technology:New Elekta Consortium to Push Frontiers of Linear Accelerator-Based Stereotactic Radiation Therapy for the Brain 2New Elekta Consortium to Push Frontiers of Linear Accelerator-Based Stereotactic Radiation Therapy for the Brain 3Pulmonary Fibrosis Foundation and Veracyte Partner on Survey Exploring Diagnostic Experiences of U.S. Patients with Interstitial Lung Disease 2Pulmonary Fibrosis Foundation and Veracyte Partner on Survey Exploring Diagnostic Experiences of U.S. Patients with Interstitial Lung Disease 3Pulmonary Fibrosis Foundation and Veracyte Partner on Survey Exploring Diagnostic Experiences of U.S. Patients with Interstitial Lung Disease 4DelMar Pharmaceuticals to Announce Fiscal 2015 Year-End Financial Results on September 4, 2015 2DelMar Pharmaceuticals to Announce Fiscal 2015 Year-End Financial Results on September 4, 2015 3
... 6, 2011 Solos Endoscopy, Inc. (OTCPK: SNDY) announced ... National Breast Cancer Foundation (NBCF) by donating 5% of ... for the month of October to the NBCF. Solos ... across the Country through direct sales channels and social ...
... Va., Oct. 6, 2011 U.S. prescription sales through ... in 2010 — representing 87 percent of pharmaceutical sales ... Factbook . Now in its 83rd ... the Center for Healthcare Supply Chain Research, is a ...
Cached Medicine Technology:Solos Endoscopy to Support National Breast Cancer Foundation With Sales of Its MammoView® Breast Endoscopy Components to US Hospitals 2Prescription Sales Through Healthcare Distributors Hit $268 Billion 2Prescription Sales Through Healthcare Distributors Hit $268 Billion 3
Near PT test card/4 1/2 to 12 PT in spanish & french /5 1/2" X 8....
Card has Jaeger rating and snellen equivalent....
Near point card 4 1/2 to 24 PT 5 1/2" x 8"....
... is specially designed to be a corrected Rosenbaum ... card (as noted by Horton and Jones in ... notations are not used because of the lack ... Wormington NP Card, the examiner can measure a ...
Medicine Products: