Navigation Links
Biopharmaceutical Company, Cephalon, To Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing
Date:9/29/2008

remedy for anxiety, insomnia and pain. In 2005, following reports of seizures in patients taking Gabitril who did not have epilepsy, the FDA required Cephalon to send a warning letter to doctors advising of the connection between off-label Gabitril use and seizures. The company then ceased promotion of the drug.

Provigil was first approved to treat excessive daytime sleepiness associated with narcolepsy, then expanded the label to include treatment of excessive sleepiness associated with sleep apnea and shift work sleep disorder. From 2001 through 2006, Cephalon allegedly promoted Provigil as a non-stimulant drug for the treatment of sleepiness, tiredness, decreased activity, lack of energy and fatigue. In 2002, the FDA sent Cephalon a letter warning the company not to continue to promote Provigil off-label.

Cephalon undertook its off-label promotional practices via a variety of techniques, such as training its sales force to disregard restrictions of the FDA-approved label, and to promote the drugs for off-label uses.

For example, the Actiq label stated that the drug was for "opioid tolerant cancer patients with breakthrough cancer pain, to be prescribed by oncologist or pain specialists familiar with opioids." Using the mantra "pain is pain," Cephalon instructed the Actiq sales representatives to focus on physicians other than oncologists, including general practitioners, and to promote this drug for many uses other than breakthrough cancer pain.

In the case of Gabitril, which had been approved for use for epilepsy, Cephalon told the sales force to visit not just neurologists, but also psychiatrists, and to promote the drug for anxiety and other psychiatric indications. Cephalon also structured its sales quota and bonuses in such a way that sales representatives could only reach their sales goals if they promoted and sold the drugs for off-label uses.

Cephalon employed sales representatives and retained medical professionals to s
'/>"/>

SOURCE U.S. Department of Justice
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Presentation Time Correction: Keryx Biopharmaceuticals Presents at 12:00pm, ET Tomorrow (Oct. 3) at William Blair & Company Small-Cap Growth Stock Conference
2. Nabi Biopharmaceuticals Announces Third Quarter 2007 Financial Results and Positive Vote from November 8, 2007 Special Stockholders Meeting
3. Nabi Biopharmaceuticals Completes Sale of Nabi Biologics to Biotest AG
4. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) to be Presented at the Upcoming American Society of Hematology Meeting in Atlanta, Georgia
5. XTL Biopharmaceuticals Announces Financial Results for the Year Ended December 31, 2007
6. Immunosyn Announces Proposed Agreements for Distribution of the Biopharmaceutical SF-1019 in Utah
7. Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2008 Financial Results
8. Independence Technology, A Johnson & Johnson Company, Renews Its Contract With Creative Technology Services
9. Tela Sourcing, Inc., an Adaptis Company, Acquires HealthASPex Business
10. Nevada company, ORNL develop potential lifesaver
11. ForSight Labs, LLC Announces Formation of Its Third Company, ForSight VISION3, Inc. and Closing of $6 Million in Series A Funding
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... (PRWEB) January 23, 2015 AngelWeddingDress, the ... of 2015 maternity wedding dresses. View website ... are looking for maternity wedding dresses online for a ... gowns with high quality for them. Its maternity wedding ...
(Date:1/22/2015)... A new white paper by The Beryl ... the long-term care environment as well as provides recommendations ... paper, “The Power of Person-Centeredness in Long-Term Care: A ... the patient, resident and family experience in long-term care ...
(Date:1/22/2015)... January 22, 2015 For over 20 years, Dr. ... Oceanside and Vista area has treated just about every type ... injury circumstances. And for those same twenty-plus years, the team ... all those injuries with the best possible doctor. With ...
(Date:1/22/2015)... 22, 2015 A study recently ... flagship journal Medicine & Science in Sports & ... may help reduce gastrointestinal (GI) problems associated with ... Participants in the double-blind, placebo-controlled study took 10 ...
(Date:1/22/2015)... January 22, 2015 IsoComforter, Inc. has introduced ... with patented IsoTube design to treat specific body parts and ... most progressive and easy to use patented cold therapy machine ... sports related orthopedic and muscle injuries. IsoComforter has become ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2
... no survival difference for those with, without device , WEDNESDAY, ... first weeks after a heart attack does not improve survival, ... cardiac arrest occurred among those given the devices, which shock ... was about the same as for those who did not ...
... Researchers identify possible genetic links, but urge further study ... and genomic regions that might be associated with autism ... The researchers identified a single-letter change on chromosome 5 ... to help guide the growth of neurons and their ...
... Each year, an estimated 800,000 Americans will ... the victims survive, but their lives, and those of ... victims can suffer from a multitude of problems, including ... sleep disturbances. , Careforward , an organization ...
... (NYSE: CRDA ; CRDB) European third party administration ... of Broadspire, a Crawford company, continuing the leading TPA,s ... CRDA ; CRDB), the world,s largest independent provider of ... Broadspire brand at the Federation of European Risk Management ...
... VIEW, Calif., Oct. 7 Satellite Healthcare, one of ... services and a major sponsor of nephrology research, today ... 21st Annual San Francisco Author,s Luncheon. , The ... year more than 1,200 people are captivated by the ...
... 7 Coverall Health-Based Cleaning System(SM), a leading franchisor of ... as one of the "50 Top Franchises for Minorities" ... third year in a row. The list of top ... Today, the national daily newspaper. Coverall was also honored ...
Cached Medicine News:Health News:Early Defibrillator After Heart Attack May Not Pay Off 2Health News:Early Defibrillator After Heart Attack May Not Pay Off 3Health News:Potential Pieces of Autism Puzzle Revealed 2Health News:Mingling, Martinis & Mysterious Murder Masquerade at the Whitney to Benefit Carnival of Care 2Health News:Crawford & Company's Broadspire Unit Continues Its European Expansion 2Health News:Satellite Healthcare Partners With the National Kidney Foundation for the 21st Annual San Francisco Author's Luncheon 2Health News:Coverall Named Among '50 Top Franchises for Minorities' for Third Consecutive Year 2
(Date:1/23/2015)... , Jan. 23, 2015 Research and Markets ... the "Urinary Catheters Market (Indwelling or Foley Catheters, ... Global Industry Analysis, Size, Share, Growth, Trends and Forecast ... , At present, the global market for ...
(Date:1/23/2015)... a third of reproductive-aged women enrolled in Medicaid, and more ... prescription for an opioid pain medication each year during 2008-2012, ... Weekly Report (MMWR). Opioids are typically prescribed ... They are also found in some prescription cough medications. The ...
(Date:1/23/2015)... MERIDIAN, Idaho , Jan. 23, 2015  Now available ... Patent No. 7,849,611) support that prevents ankle sprains by ... a brace, it fits securely around the outside of ... ankle mobility & comfort while still offering protection against ...
Breaking Medicine Technology:Urinary Catheters Market (Indwelling or Foley Catheters, Intermittent Catheters and Male External or Condom Catheters) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Urinary Catheters Market (Indwelling or Foley Catheters, Intermittent Catheters and Male External or Condom Catheters) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2
... PARK, N.C., April 25, 2011 GlaxoSmithKline (GSK) announced ... has approved Lamictal® XR™ (lamotrigine) Extended-Release Tablets ... older with partial seizures taking one anti-epileptic drug. This ... XR which is already approved as add-on treatment ...
... eye doctors , Rockland Eye Physicians and Surgeons, one of ... use of Alcon,s cutting edge AcrySof IQ ReSTOR IOL available ... other cataract treatments in that it allows the ... the use of bifocals or trifocals in many situations. ...
Cached Medicine Technology:FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients 2FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients 3FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients 4FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients 5Renowned New York Ophthalmologists, Drs. Glen Weiss and Robert Chen of Rockland Eye Physicians Use the AcrySof IQ ReSTOR IOL to Correct Cataracts Without Glasses 2Renowned New York Ophthalmologists, Drs. Glen Weiss and Robert Chen of Rockland Eye Physicians Use the AcrySof IQ ReSTOR IOL to Correct Cataracts Without Glasses 3
ACE Control Serum provides the laboratory with vital information on the performance of the ACE chemistry assay....
Medical Claims Billing...
e-MDs Bill practice management system is used in the medical billing cycle....
BillingPro...
Medicine Products: