Navigation Links
Cephalon Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA
Date:5/6/2008

is not required to follow the Committee's guidance, but the agency does take this advice into consideration when reviewing a proposed label expansion.

Conference Call for Investors

Cephalon management will discuss the FDA Advisory Committee proceedings with investors during a conference call beginning at 5:30 p.m. EDT today. To participate in the conference call, dial 1-913-312-0407 and refer to conference call ID number 2046179. Individual investors are encouraged to log onto the investor relations section of http://www.cephalon.com and click on the webcast to access the live call.

PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT WARNINGS IN THIS LABEL.

Reports of serious adverse events, including deaths in patients treated with FENTORA 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 FENTORA for any other fentanyl product may result in fatal overdose.

FENTORA is indicated only for the management of breakthrough pain in patients with cancer 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 oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid daily for a week or longer.

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

FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Death
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine news :

1. Cephalon Conference Call Invitation
2. Cephalon Reports Strong First Quarter Earnings
3. Cephalon Appoints Gerald J. Pappert as General Counsel
4. inVentiv Selling Solutions Selected to Provide Sales Team for Cephalon Inc.
5. Cephalon to Present at the 26th Annual JP Morgan Healthcare Conference
6. Cephalon Appoints Valli F. Baldassano as Executive Vice President and Chief Compliance Officer
7. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
8. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
9. Mergent, Inc. Announces Changes to the HealthShares(TM) Composite, Enabling Technologies, Autoimmune-Inflammation, Cancer, Cardiology and Neuroscience Indexes
10. WebMD Announces First Quarter Financial Results
11. HLTH Corporation Announces First Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/18/2014)... a brain-related discovery that could revolutionize doctors, perception ... opens up the possibility that environmental and/or genetic ... activity that the researchers have identified as helping ... Neuroscience has just published a paper about ... of psychology and his doctoral student John Gaspar, ...
(Date:4/17/2014)... chronic inflammation in non-cancerous prostate tissue may have nearly ... those with no inflammation, according to results of a ... Kimmel Cancer Center. , The link between persistent inflammation ... high-grade prostate cancer those with a Gleason score ... the most aggressive and rapidly growing prostate cancers. , ...
(Date:4/17/2014)... the April issue of Experimental Biology and ... Drs. Rex Gaskins and Paul Kenis in the ... of the University of Illinois Urbana-Champaign describe their ... reactions underlie a variety of cell functions including ... these crucial roles in regulating normal cellular behavior, ...
(Date:4/17/2014)... has created a new technology for modifying human ... the body and selectively target cancer and other ... that monitor and modify human physiology is a ... existing technology enabled bioengineers to build such devices ... in a customized fashion. , "The project addressed ...
(Date:4/17/2014)... affects about one in five infants in the United ... the first several months after birth. Research into probiotic ... however, the April 1, 2014 issue of the ... a study, "Probiotics and Infant Colic," concluding that the ... infant colic did not reduce crying or fussing ...
Breaking Medicine News(10 mins):Health News:Scientists discover brain's anti-distraction system 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Live cell imaging reveals distinct alterations of subcellular glutathione potentials 2Health News:Building 'smart' cell-based therapies 2Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2
... in those who listened just a few hours a day ... for a few hours a day can help boost a ... study of 54 patients who,d suffered a stroke of the ... who listened to music for a few hours a day ...
... Does exposure of baby boys -- in utero or in ... natural estrogens, predispose them to prostate cancer later in life? ... Illinois at Chicago researcher and her colleague aims to answer ... it may occur. , Gail Prins, professor of urology at ...
... This release is available in French . , ... battle in the fight against age-related macular degeneration, or AMD, ... international team, led by researchers at Sainte-Justine Hospital and the ... the dry form of AMD. , In the February ...
... an active material could be used to remove toxic ... much more effectively and at lower cost than conventional ... current issue of the International Journal of Nanotechnology. , ... Wark Research Institute, at the University of South Australia, ...
... Feb. 20 HIV/AIDS is still a,taboo topic among ... to change this. For Dinah Ayna, talking about HIV ... is a challenging, yet a rewarding,part of her daily ... are 3.5 million Arab,Americans in the U.S. One-third live ...
... 20 LifeSync Corporation is,pleased to announce the ... of Research and Development. Dr. Phelps, who will ... responsible for leading all,product design and development at ... Georgia Electronic Design Center (GEDC),at the Georgia Institute ...
Cached Medicine News:Health News:Music Therapy Improves Stroke Outcomes 2Health News:Grant to study if early BPA exposure leads to late prostate cancer 2Health News:AMD discovery: New hope for treatment of vision loss 2Health News:Cleaner water through nanotechnology 2Health News:Breaking Down Barriers: A Woman's Path to Reducing HIV Stigma in the Arab American Community 2Health News:LifeSync Hires Dr. Mark Phelps to Lead Research & Development 2
(Date:1/15/2014)... , Jan. 15, 2014 The Cadence Fitness & ... Center by the Medical Fitness Association, a non-profit organization ... their full potential. The Cadence Fitness & Health Center ... suburbs and second in the Chicagoland area. ...
(Date:1/15/2014)... 15, 2014 Reportlinker.com announces that a ... its catalogue: Insulin ... http://www.reportlinker.com/p01957812/Insulin-Pump-Market--Forecast-–-Worldwide-Analysis.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Equipment_and_Supply ... Insulin Pumps are gaining strong ...
(Date:1/15/2014)... 15, 2014  Valeant Pharmaceuticals International, Inc. (NYSE: ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... offer by its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ... stock of Solta Medical, Inc. (NASDAQ: SLTM ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Insulin Pump Market & Forecast - Worldwide Analysis 2Insulin Pump Market & Forecast - Worldwide Analysis 3Insulin Pump Market & Forecast - Worldwide Analysis 4Insulin Pump Market & Forecast - Worldwide Analysis 5Insulin Pump Market & Forecast - Worldwide Analysis 6Insulin Pump Market & Forecast - Worldwide Analysis 7Insulin Pump Market & Forecast - Worldwide Analysis 8Insulin Pump Market & Forecast - Worldwide Analysis 9Insulin Pump Market & Forecast - Worldwide Analysis 10Insulin Pump Market & Forecast - Worldwide Analysis 11Insulin Pump Market & Forecast - Worldwide Analysis 12Insulin Pump Market & Forecast - Worldwide Analysis 13Insulin Pump Market & Forecast - Worldwide Analysis 14Insulin Pump Market & Forecast - Worldwide Analysis 15Insulin Pump Market & Forecast - Worldwide Analysis 16Insulin Pump Market & Forecast - Worldwide Analysis 17Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3
... infant benefits from cutting-edge treatment, CHARLESTON, S.C., ... Sandin of Charleston was diagnosed with craniosynostosis, a,condition ... sutures, or,fontanels, causing problems with normal brain and ... the condition, Amelia,s skull was,growing in an asymmetrical ...
... AstraZeneca (NYSE:,AZN) today announced that it submitted a ... and Drug Administration (FDA) for approval of a ... the treatment of patients with Chronic Obstructive,Pulmonary Disease ... treatment of asthma in patients 12 years and ...
Cached Medicine Technology:STARscanner, STARband Cranial Helmets Making a Difference in the Lives of Children 2STARscanner, STARband Cranial Helmets Making a Difference in the Lives of Children 3AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication 2AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication 3AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication 4AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication 5
For use with E0828 A needle tip and E0828 B gouge tip. Round knurled with threaded ended for tips. Most popular size or model....
Handle will hold E0824 A replacement burrs and E0813 Pterigium diamond burrs. Round knurled handle. Most popular size or model....
Set consists of one each:E0824 A replacement burr set. E0824 B handle....
0.5 mm replacement burr for Algerbrush rust ring remover (E0815 A). Burr can also be used with Algerbrush rust ring remover (E0815 B). Dull finish....
Medicine Products: