Navigation Links
Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
Date:9/15/2008

FDA Requests Enhancements to Risk Mitigation Strategies Consistent with

Company's Recommendations

FRAZER, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today receipt of a complete response letter from the Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment for opioid-tolerant patients with non-cancer breakthrough pain. In its letter, the FDA requested that Cephalon implement and demonstrate the effectiveness of proposed enhancements to the current FENTORA risk management program. These enhancements are consistent with the strategies the company presented at the FDA Advisory Board meeting on May 6, 2008. The agency also requested routine safety updates; no additional safety or efficacy studies were requested. In accordance with new FDA regulations, the company anticipates receiving a second communication from the agency requesting that the FENTORA Risk Minimization Action Plan (RiskMAP) be converted to incorporate the new standards for the Risk Evaluation and Mitigation Strategy (REMS) safety plan.

"The FDA request for revisions to the FENTORA risk management program was expected and over the last four months we have been working diligently to prepare for implementation of the program as soon as possible. We anticipate that the subsequent letter from the agency will provide useful guidance to finalize the timeline for and implementation of ongoing enhancements to the risk management program," said Dr. Lesley Russell, Executive Vice President and Chief Medical Officer at Cephalon. "We intend to put into place a REMS that we hope will not only demonstrate effectiveness for mitigating the risks associated with FENTORA but also pave the way for a new industry standard for opioid pain medications."

To address the FDA's request in the complete response letter, Cephalon plans to implement COVERS(
'/>"/>

SOURCE Cephalon, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Journal of Clinical Oncology Publishes Study of Cephalon Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkins Lymphoma
2. Cephalon Announces Positive Results from Its Pivotal Study of TREANDA in Patients with Non-Hodgkins Lymphoma
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. Theranostics Health Receives Green Light to Perform Clinical Testing
5. StemCor Systems Receives CE Mark for MarrowMiner(TM) System for Bone Marrow Collection
6. Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing
7. Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351
8. Unique Hearing Aid Receives Patent Protection
9. Tobira Therapeutics Inc. Receives US Patent for TBR-652
10. Inverness Medical Innovations Receives USDA Licensure of the BinaxNOW(R) Avian Influenza Virus Type A Antigen Test Kit
11. Nexgen Spine Receives CE Mark Approval for the Physio-L(R) Artificial Disc
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... Texas, Aug. 3, 2015  Luminex Corporation (NASDAQ: ... quarter ended June 30, 2015.  Financial and operating highlights ... Increased second quarter 2015 revenue by 6 percent to ... , Grew second quarter 2015 assay revenue by 22 ... quarter of 2014. , Increased Q2 2015 royalty ...
(Date:8/3/2015)... DRRX ) announced today financial results for the second ... loss was $5.5 million for the three months ended June ... and net loss of $5.5 million for the three months ... and investments of $37.8 million, compared to cash and investments ... 2015, we had $19.8 million in long term debt. ...
(Date:8/3/2015)... CHICAGO , August 3, 2015 ... Report 2015 market research with 2020 forecasts as ... the healthcare and medical devices intelligence collection of ... medical simulation market with 2020 forecasts spread across ... supported with 170 tables and figures is now ...
Breaking Medicine Technology:Luminex Corporation Reports Record 2nd Quarter 2015 Results 2Luminex Corporation Reports Record 2nd Quarter 2015 Results 3Luminex Corporation Reports Record 2nd Quarter 2015 Results 4Luminex Corporation Reports Record 2nd Quarter 2015 Results 5Luminex Corporation Reports Record 2nd Quarter 2015 Results 6Luminex Corporation Reports Record 2nd Quarter 2015 Results 7Luminex Corporation Reports Record 2nd Quarter 2015 Results 8Luminex Corporation Reports Record 2nd Quarter 2015 Results 9Luminex Corporation Reports Record 2nd Quarter 2015 Results 10Luminex Corporation Reports Record 2nd Quarter 2015 Results 11Luminex Corporation Reports Record 2nd Quarter 2015 Results 12Luminex Corporation Reports Record 2nd Quarter 2015 Results 13Luminex Corporation Reports Record 2nd Quarter 2015 Results 14Luminex Corporation Reports Record 2nd Quarter 2015 Results 15Luminex Corporation Reports Record 2nd Quarter 2015 Results 16DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 2DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 3DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 4DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 5DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 6DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 7DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 8DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 9DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs 10Medical Simulation Market to see 14% CAGR to 2019 2Medical Simulation Market to see 14% CAGR to 2019 3Medical Simulation Market to see 14% CAGR to 2019 4Medical Simulation Market to see 14% CAGR to 2019 5Medical Simulation Market to see 14% CAGR to 2019 6
... 2011 ImpactRx, the pioneer in measuring the ... the rollout of POP 2.0, a proprietary, event-triggered ... physician panels. Triggered by events already ... POP (Point-of-Promotion/Point-of-Prescribing) surveys enable ImpactRx to uniquely capture ...
... Ore., June 27, 2011 Bend Research Inc. ( www.bendresearch.com ... named a new president. Jim Nightingale, who ... fourth president in the firm,s 36-year history. ... capacity as Bend Research Chief Executive Officer (CEO) and chairman ...
Cached Medicine Technology:Enhanced POP 2.0 Provides Custom Insight Into the Physician's Mindset at the Point of Promotion and Prescribing 2Bend Research Inc. Names New President 2
(Date:8/3/2015)... ... August 03, 2015 , ... Zeiter’s Septic now performs septic ... owned and operated business, Zeiter’s Septic has been serving the community for over ... installations because of their continued training and perseverance to provide their customers with ...
(Date:8/3/2015)... UT (PRWEB) , ... August 03, 2015 , ... ... of the T500 cable , a Bluetooth Code Reader accessory that enables a ... iOS products. The T500 helps enable a variety of barcode reading applications with ...
(Date:8/3/2015)... ... August 03, 2015 , ... Bayer has agreed to pay $56.9 million ... which a claimant alleged to have suffered an arterial blood clot including stroke and ... Yaz, Yasmin and Ocella, has been ongoing for well-over five years. In 2009, lawsuits ...
(Date:8/3/2015)... ... August 03, 2015 , ... Novation, the ... to offer pharmacogenetic lab testing and precision medicine solutions that can help pharmacists ... , Annually, more than 8.6 million adverse drug events are reported in the ...
(Date:8/3/2015)... (PRWEB) , ... August 03, 2015 , ... ... from ALS and amputation , AUGUST 3, 2015 – Since winning a South ... March 2015, Not Impossible – an organization whose mission is to develop technology ...
Breaking Medicine News(10 mins):Health News:Zeiter’s Septics Performs Affordable Septic Installations Throughout Livingston & Putnam Counties Effective Immediately 2Health News:Zeiter’s Septics Performs Affordable Septic Installations Throughout Livingston & Putnam Counties Effective Immediately 3Health News:Code Launches the T500, an Innovative Code Reader Accessory 2Health News:Code Launches the T500, an Innovative Code Reader Accessory 3Health News:Bayer Agrees To Settle Yaz Aterial Blood Clot Lawsuits 2Health News:Novation Awards Genelex First Group Purchasing Agreement for Pharmacogenetic Testing and Precision Medicine Software 2Health News:Novation Awards Genelex First Group Purchasing Agreement for Pharmacogenetic Testing and Precision Medicine Software 3Health News:Not Impossible Earns Top Awards for Technologies Benefiting Humanity 2Health News:Not Impossible Earns Top Awards for Technologies Benefiting Humanity 3Health News:Not Impossible Earns Top Awards for Technologies Benefiting Humanity 4
... have therapeutic benefits , WEDNESDAY, July 22 (HealthDay News) ... in efforts to develop drug treatments for diabetes and ... they found that humanin, which may prevent nerve cells ... blood glucose levels. , "This new role of humanin ...
... , INDIANAPOLIS, July 22 Roche Diagnostics ... comprehensive testing solution for rapid cardiac diagnostic needs in point-of-care ... The latest addition to an expanding portfolio of Roche Diagnostics ... immunoassay testing system designed to provide quantitative cardiac marker test ...
... , RONKONKOMA, N.Y., July 22 NBTY, Inc. ... marketer of nutritional supplements, today announced it will web cast a conference call ... www.NBTY.com ), on Monday, July 27, 2009 at 9:00 AM (ET). ... at 7:00 AM (ET) that morning. , , ...
... , , ... July 22 Decision Resources, one of the world,s leading ... finds that surveyed rheumatologists, perception of Bristol-Myers Squibb,s Orencia is ... the agent when compared to tumor necrosis factor-alpha (TNF-alpha) inhibitors ...
... WALTHAM, Mass., July 22 According to ... technology market intelligence, the recent Centers for Medicare and ... are resulting in adoption of antimicrobial-coated access devices, including ... US Markets for Vascular Access Devices 2009 report ...
... Dr. Robert Graw announced Nighttime Care Centers opened its seventh urgent ... Center at 882 Muddy Branch Road, Gaithersburg, Maryland 20878. Nighttime Care ... adults when residents do not have access to their regular physicians. ... , "This Care Center will help round ...
Cached Medicine News:Health News:Roche Cardiac 200 Offers Rapid Cardiac Diagnostics for the Point of Care 2Health News:Roche Cardiac 200 Offers Rapid Cardiac Diagnostics for the Point of Care 3Health News:NBTY to Web Cast Fiscal Third Quarter Conference Call 2Health News:For Treatment of Rheumatoid Arthritis, Surveyed Rheumatologists and Patients Differ In Their Perception of Bristol-Myers Squibb's Orencia 2Health News:For Treatment of Rheumatoid Arthritis, Surveyed Rheumatologists and Patients Differ In Their Perception of Bristol-Myers Squibb's Orencia 3Health News:Following CMS Cuts to Reimbursement for Medical Errors, New Devices Aimed at Reducing Nosocomial Infections Emerge 2Health News:Following CMS Cuts to Reimbursement for Medical Errors, New Devices Aimed at Reducing Nosocomial Infections Emerge 3Health News:Nighttime Care Centers Announces New Urgent Care Medical Clinic in Montgomery County, Maryland 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: