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:10/22/2014)... Oct. 22, 2014 AVACEN Medical announced today ... 510 (k) OTC clearance by the U.S. Food and ... be marketed over the Internet for: the temporary ... and minor strains and sprains . Logo ... 100 (MSRP $2495) is a sophisticated medical device incorporating ...
(Date:10/22/2014)... YARDLEY, Pa. , Oct. 22, 2014 /PRNewswire/ ... of their animal health medications, a Global Pharmaceutical ... and Antares serialization technology and turnkey solution to ... Photo - http://photos.prnewswire.com/prnh/20141021/153438 ... The product that was serialized and aggregated by ...
(Date:10/22/2014)... , Oct. 21, 2014  Early symptoms of ... or unnoticed, but new technology, coupled with yearly, ... leading to earlier detection of eye diseases, including ... million Americans. If left untreated, these diseases can ... Recently, optometric researchers have deployed ...
Breaking Medicine Technology:AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2Xyntek and Antares Serialization Solution Protects Pets Too! 2Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 2Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 3
... , , , ... (PMO) in Ohio and more than 900,000(3) are at risk for the ... the number of women suffering from the disease is predicted to increase ... predicted increase, a national Harris Interactive survey commissioned by the Know ...
... COLLEGEVILLE, Pa., July 27 ... WYE ), announced the publication in Fertility and Sterility ... showed that the investigational compound bazedoxifene/conjugated estrogens (BZA/CE) significantly reduced ... of vaginal atrophy when compared to placebo. In this study, ...
Cached Medicine Technology:Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 2Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 3Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 4Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 5Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 6Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 7Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 8Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease 9Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms 2Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms 3Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms 4Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms 5Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms 6
(Date:10/22/2014)... 22, 2014 Best Cheap Hosting USA ... world. The site has recently announced that iPower ( ... for people from around the world. , “iPower is ... today and is providing various kinds of useful products ... insists on offering excellent customer service and a number ...
(Date:10/22/2014)... 2014 Losing Weight Your Body’s Way , ... you in the face, it certainly can be difficult to ... body an extra favor by doing it the healthy way? ... Instead, listen to your body, exercise regularly, and choose foods ... to losing weight; you need to exercise more and eat ...
(Date:10/22/2014)... Lintelus, Inc., an event software provider, ... Sales, will be speaking on the subject of “Event ... October 28, at the Holiday Inn in New York ... well as a Tech Demo at 12:45pm, to educate ... more engaging event experience. , The Annual Meetings Technology ...
(Date:10/22/2014)... 2014 Akeso Biomedical, Inc. , ... treatment of bacterial infections, microbial biofilms, and chronic wounds, ... board of directors. , Dr. Sinskey ... The Massachusetts Institute of Technology, or MIT. He has ... Dr. Sinskey also holds positions as Co-Director of the ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, 2014 ... are only about half as likely as white women to ... indicates, and the racial disparity persists even when donor eggs ... white patients became pregnant after IVF, compared to about 17 ... cycles over two years to tease out the impact of ...
Breaking Medicine News(10 mins):Health News:Best Cheap Hosting USA Has Recently Announced The Best Cheap Web Hosting Companies In 2014 2Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2Health News:Jay Cormier, Sr. Vice President of Sales for Lintelus, Speaks about Event Technology Integration at Meetings Technology Expo in NYC 2Health News:Akeso Biomedical Appoints Dr. Anthony J. Sinskey to Board of Directors 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 3
... NEW YORK, SEATLLE, GAINESVILLE, Fla. and SUNNYVALE, Calif., ... quality of care for Parkinson,s patients, the National ... physicians, physician assistants, nurses, physical therapists, speech-language pathologists, ... teach the latest methods of Parkinson diagnosis and ...
... from bone marrow may serve as a novel therapeutic option ... characterized by extraordinarily fragile skin, according to a study pre-published ... American Society of Hematology. , , ... fragile skin and blistering on touch, akin to third degree ...
... Although there are many issues,facing Americans throughout the country ... Holiday Season is always viewed as a joyous time to ... even more difficult for,those people who have experienced the death ... this year, may now echo with greater,sadness, emptiness and loss. ...
... Pittsburgh-based Foundation Radiology,Group (FRG) was named by the Radiology Business ... the country. Located in Gateway Center in downtown,Pittsburgh, FRG has ... get,recognized by industry leaders and national experts. , ... of being in operation, FRG was ranked 44th out of,50 ...
... Health Insurer Brings More Jobs to Lodi , ... forward with its long-term commitment to the Lodi community, Blue ... Lodi customer service center today with a ribbon-cutting ceremony at ... families from 5:00 - 7:00 p.m. The new facility ...
... Bermuda, Dec. 4 The Board of Directors of Tyco International Ltd. ... cash dividend of $0.20 per common share. The dividend is payable ... 2009. , , ABOUT TYCO ... is a diversified, global company that provides vital products and services to ...
Cached Medicine News:Health News:Allied Team Training For Parkinson 2Health News:Bone Marrow-Derived Stem Cells May Offer Novel Therapeutic Option for Skin Disorder 2Health News:Bone Marrow-Derived Stem Cells May Offer Novel Therapeutic Option for Skin Disorder 3Health News:Bone Marrow-Derived Stem Cells May Offer Novel Therapeutic Option for Skin Disorder 4Health News:In-House Hospice Offers Help to Those Living With Grief During Holiday Time 2Health News:Foundation Radiology Group Named One of 50 Largest Radiology Groups in the Country 2Health News:Blue Shield of California Celebrates Completion of New Lodi Campus 2Health News:Blue Shield of California Celebrates Completion of New Lodi Campus 3
Each handle is designed to fit a specific trephine size....
Reusable, stainless steel trephine with handle....
Reusable, stainless steel trephine with handle....
Reusable, stainless steel trephine with handle....
Medicine Products: