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. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by ProEthic Pharmaceuticals under the label Lipofen(TM). In addition, Cipher is developing formulations of the pain reliever tramadol and the acne treatment isotretinoin.

Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit http://www.cipherpharma.com.

Forward-Looking Statements

Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. The Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.


'/>"/>
SOURCE Cipher Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:2/27/2017)... ... 27, 2017 , ... Much attention has been paid to the problem of ... opioid painkillers has fallen short. From 1999 until 2010, fatal overdoses from prescription pain ... overdoses in male populations.(1) , The proportion of women using illicit drugs is also ...
(Date:2/27/2017)... ... 2017 , ... Elisa Guajardo Carothers is not your typical author. She went from working as ... Now, she writes about God, when she isn’t swimming as a performing mermaid. , Her ... BS! (Before Satan),” she offers a comedic look at the dysfunctions of God’s family, before ...
(Date:2/27/2017)... ... February 27, 2017 , ... ... on laser diffraction analysis as a tool to characterize particle size distributions in ... to obtain improved results and novel scientific findings. It describes methods of optimized ...
(Date:2/27/2017)... POUGHKEEPSIE, N. Y. (PRWEB) , ... February 27, 2017 , ... ... Society ( ILADS ) has disclosed that despite scientific studies, the Center for Disease ... of chronic Lyme disease . Kenneth B. Liegner, M.D. has compiled into ...
(Date:2/27/2017)... , ... February 27, 2017 , ... ... and alcohol treatment programs in British Columbia, Canada, at https://www.sunshinecoasthealthcentre.ca/ , is ... team. The new hire, Mackenzie Alsager, showcases the Centre's commitment to innovation in ...
Breaking Medicine News(10 mins):
(Date:2/27/2017)... OCEAN VIEW, Delaware , February 27, 2017 ... (Software, Hardware, Services), By Product (Enterprise Based, Site Based), By Delivery Mode ... Research Organizations, Healthcare Providers), Industry Analysis Report, Regional Outlook (U.S., ... , Poland , Russia , ... Japan , South Korea , Taiwan ...
(Date:2/27/2017)... , Feb. 27, 2017   Royal Philips ... a global leader in health technology, today announced ... Administration (FDA) to market its ElastQ Imaging capability, ... of ultrasound systems. ElastQ Imaging enables simultaneous imaging ... is essential for the diagnosis of various liver ...
(Date:2/27/2017)... 27, 2017  RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ... company focused on tissue protection, repair and regeneration, ... Co., Ltd., received a positive response from the ... design for RGN-137 to treat epidermolysis bullosa ("EB"). ... incorporates Thymosin beta 4 ("Tß4") as the active ...
Breaking Medicine Technology: