Cipher provides CIP-TRAMADOL ER regulat... ( Toronto Stock Ex...)

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
'/>"/>

0

GOOD

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:

Cipher provides CIP-TRAMADOL ER regulat...( Toronto Stock Ex...),Health