Navigation Links
Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ
Date:7/21/2011

ng to patients appropriate for the medications.  All stakeholders can enroll in the system any time beginning in September 2011.  There will be a transition period of about six months following launch of the REMS after which no prescription may be dispensed unless the prescriber and pharmacy are enrolled.    

Cephalon will provide regular updates to FDA regarding the effectiveness of the REMS.  Based on these evaluations, Cephalon plans to open discussions with FDA regarding the Company's pending supplemental New Drug Application for FENTORA as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.

Important Safety Information

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE

Reports of serious adverse events, including deaths in patients treated with ACTIQ® have been reported.  Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of ACTIQ for any other fentanyl product may result in fatal overdose.

ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

ACTIQ is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.

Life-threatening respiratory depression could occur at any dose in opioid non-tolerant pa
'/>"/>

SOURCE Cephalon, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Cephalon Shareholders Approve Acquisition by Teva
2. Valeant Pharmaceuticals Congratulates Teva and Cephalon on Their Transaction
3. Valeant Pharmaceuticals Responds to Cephalon Boards Letter
4. Valeant Pharmaceuticals Adds Corporate Governance Expert Abe Friedman to its Slate of Proposed Cephalon Directors
5. Cephalon Lodges Bidders Statement for A$167 Million Offer for ChemGenex Pharmaceuticals
6. Valeant Pharmaceuticals Files Presentation for Cephalon Stockholders
7. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
8. Cephalon Launches Recommended Takeover Bid For Australian Biopharmaceutical Company, ChemGenex Pharmaceuticals Limited
9. Cephalon Wins FENTORA Patent Suit Against Watson
10. Cephalon Announces Definitive Agreement to Acquire Gemin X
11. Cephalon Reported Record Sales, Adjusted Net Income and Cash From Operations in 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... JUNCTION, N.J. , May 4, 2015 /PRNewswire/ ... care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine ... in multiple countries worldwide, will report Q1 2015 ... May 11, 2015.  CytoSorbents, management ... webcast that will recount both operational and financial ...
(Date:5/4/2015)... -- Concord Medical Services Holdings Limited ("CCM" or the "Company") ... provider and operator of the largest network of radiotherapy and ... today that an Extraordinary General Meeting ("EGM") will be held ... time) at CCM,s office at 18/F, Tower A, ... District, Beijing, P.R. China . ...
(Date:5/4/2015)... /PRNewswire/ - YOLO Medical Inc. , ("YOLO") ... of medical and aesthetic devices, proudly announces that ... new generation body contouring laser system; LIPOFINA. ... low-level laser device for body contouring, creating and ... technology while continuing to push the envelope of ...
Breaking Medicine Technology:CytoSorbents to Report Q1 2015 Operating and Financial Results 2CytoSorbents to Report Q1 2015 Operating and Financial Results 3Concord Medical Services Announces 2015 Extraordinary General Meeting of Shareholders 2YOLO Medical Inc. receives FDA clearance for body contouring laser 2
(Date:5/4/2015)... (PRWEB) May 04, 2015 Sheltering Arms ... Center from Hale House. The Mother Hale Learning Center ... affordable Early Childhood Education. Sheltering Arms will begin operating ... to be served by the center. , Opened in ... ages six weeks to five years, many of whom ...
(Date:5/4/2015)... (PRWEB) May 04, 2015 Dr. Richard ... has been chosen to receive the America’s Best Dentist ... Dr. Champagne’s selection as a top dentist is a ... to continuing education and his compassion for his patients. ... professionals who exemplify excellence in their field. These nominees ...
(Date:5/4/2015)... Scanmarket, a leading provider of strategic sourcing ... the just-released Spend Matters “50 to Know” listing for ... 50 To Know " listing is a great honor ... providing comprehensive, easy-to-use strategic sourcing solutions to our customers”, ... well-established and respected companies on this list, and while ...
(Date:5/4/2015)... St. Louis, Missouri (PRWEB) May 04, 2015 ... been recognized as the “Gateway to the West,” so ... its “Gateway for Veterans Program”, says Dr. Ben Litalien, ... the International Franchise Association’s VetFran program and will provide ... , Zerorez® is proud to have a ...
(Date:5/3/2015)... Clarkston, Metamora, Michigan (PRWEB) May 03, 2015 ... ‘Like’ mark on their Facebook page. , ... patients on the many services the Practice has, it’s ... current events. , Women’s Excellence has a very strong ... +, Pinterest, Instagram and You Tube. , Women’s ...
Breaking Medicine News(10 mins):Health News:Sheltering Arms Acquires the Mother Hale Learning Center 2Health News:New Jersey Dentist Dr. Richard Champagne Nominated for America’s Best Dentist Award 2Health News:Scanmarket Selected to Spend Matters "50 To Know" List of Companies in Procurement Sector. 2Health News:Zerorez® Creates “Gateway” for Veterans--Announces VetFran Participation. Plans Expansion into the St. Louis Region. 2Health News:Zerorez® Creates “Gateway” for Veterans--Announces VetFran Participation. Plans Expansion into the St. Louis Region. 3
... drugs to enhance traits that are not fundamental to their ... Journal of Consumer Research, people,s willingness to take a ... promises to enhance is one they consider fundamental. , Authors ... University), and Geoffrey P. Goodwin (Princeton University) examine the moral ...
... likely to reuse hotel towels if they know other ... in the Journal of Consumer Research examined ... reduce unnecessary laundering. Authors Noah J. Goldstein (University of ... State University) found that the types of signs posted ...
... Eat Right, Move More and ... Milk Their Diets, BIRMINGHAM, Ala., Aug. ... different fad diets -- which seem to go in,and out of fashion like ... Americans -- including 25 percent of,Alabama residents -- remain overweight or obese., ...
... Company Reports Three-Year Sales Growth of 320% , ... ... -- Inc. today ranked CollaborateMD, a leading provider of Internet ... the healthcare industry, http://www.inc.com/inc5000/2008/company-profile.html?id=200811730 [No. 1173] on its ...
... Chairman Robert M. "Mike" Duncan released the following,statement ... "While Barack Obama campaigns on expanding health care, ... people away from care at the,University of Chicago ... rhetoric not matching his record and raises serious ...
... Class Action Lawsuit, SEATTLE, Aug. 22, A ... County Superior Court,against Milwaukee-based Extendicare Homes, Inc., Fir Lane ... facilities,in the state of Washington [see list by city ... the personal representative for the estate of Lee Ann,Steele ...
Cached Medicine News:Health News:Healthy people and enhancement drugs 2Health News:A room with a viewpoint: conservation messages and motivation 2Health News:Message to Birmingham Residents: Forgo Fad Dieting and Join the Campaign for Healthy Weight 2Health News:Message to Birmingham Residents: Forgo Fad Dieting and Join the Campaign for Healthy Weight 3Health News:CollaborateMD Ranks in Top 100 Software Companies on 2008 Inc. 5,000 2Health News:CollaborateMD Ranks in Top 100 Software Companies on 2008 Inc. 5,000 3Health News:RNC Statement Obama and Health Care 2Health News:More Legal Trouble for Elder Care Operator 2Health News:More Legal Trouble for Elder Care Operator 3Health News:More Legal Trouble for Elder Care Operator 4
... CTi Wrist is a custom wrist orthotic designed to ... patient's maximum range-of-motion. , ,Indications: , Wrist ... fibrocartilage complex , Coles fracture - distal ... Partial tendon rupture , ORIF - Open ...
The Contoured Wrist/Forearm Support provides comfort for post-surgical immobilization, post-fracture casting, and wrist sprains and strains....
... Bird and Cronin, ... manufacturer of Patient Footwear, ... Patient Care Products. Our ... highest quality and available ...
ManuTrain is an active wrist support that has optional features for increased stabilization....
Medicine Products: