Navigation Links
Cephalon Provides Update on Regulatory Review of NUVIGIL for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
Date:12/21/2009

FRAZER, Pa., Dec. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV]. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.

"We will continue to work closely with the FDA to assist them in completing their review of our application in a timely manner and do not anticipate any further delays beyond the March 29, 2010, action date," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "We remain excited about this opportunity as there are no medications approved by the FDA to treat excessive sleepiness associated with eastbound jet lag disorder."

This sNDA for NUVIGIL was filed with the FDA on June 29, 2009, and given the action date of December 29, 2009, under the Prescription Drug User Fee Act (PDUFA). The company submitted additional information within 90 days of the assigned action date. Subsequently, the FDA informed the company that the agency required more time for a full review of the submission and, therefore, would extend the action date by three months.

About NUVIGIL

NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009. It is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, th
'/>"/>

SOURCE Cephalon, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Cephalon Files Patent Infringement Lawsuit Against Teva Pharmaceuticals
2. Ception Therapeutics and Cephalon Provide Initial Results of a Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis
3. Cephalon Net Sales Increase 9% and Net Cash from Operations Surpasses $200 Million in the Third Quarter 2009
4. Cephalon Signs Option Agreement to Acquire BioAssets Development Corporation
5. Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
6. Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
7. Cephalon Provides Clinical Update on Lestaurtinib in Relapsed Acute Myelogenous Leukemia
8. Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet Lag Disorder
9. Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression
10. Cephalon Signs Option Agreement to Acquire Ception Therapeutics
11. Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... -- Kindred Hospital Houston Northwest, with Wound Care Specialists, ... new outpatient wound healing center.  The wound healing ... hard to heal wounds. Chronic wounds include diabetic ... leg wounds related to blood flow issues, post-surgical ... wounds which are complex and demonstrate delayed healing. ...
(Date:7/11/2014)... , July 11, 2014 ... 4,396.20, down 0.52%, the Dow Jones Industrial Average finished the ... at 1,964.68, down 0.41%. The losses were broad based as ... The S&P 500 Health Care Sector Index ended the day ... in the last one month. Investor-Edge has initiated coverage on ...
(Date:7/11/2014)... 11, 2014 Research and Markets ( ... "Immunoprotein Diagnostic Testing Market - Forecasts to ... of 6% and is expected to be valued ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... has been segmented according to immunoprotein types which ...
Breaking Medicine Technology:Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 3Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 4Immunoprotein Diagnostic Testing Market - Forecasts to 2019: Expected to grow at the highest CAGR of 6% and is expected to be valued at USD 4,943.0 million 2
... 2011 A letter sent by a commercial insurer ... drug use when combining anti-clotting drug clopidogrel (Plavix®) with ... in the number of members combining the drugs, according ... leader Prime Therapeutics (Prime). Details of the study will ...
... PHOENIX, April 18, 2011 Altitude Organic Corporation ... company, announced today that it has launched its ... Scottsdale headquarters.  Visit the DoctorMMJ.com website ( www.DoctorMMJ.com ... professional, and entirely legal medical marijuana evaluation in ...
Cached Medicine Technology:Study Finds Letter to Health Care Providers Results in Reduction of Potentially Unsafe Concurrent Use of Plavix and Proton Pump Inhibitors 2Altitude Organic Corporation Opens DoctorMMJ.com Physician Referral Service in Scottsdale, Arizona 2Altitude Organic Corporation Opens DoctorMMJ.com Physician Referral Service in Scottsdale, Arizona 3
(Date:7/13/2014)... 2014 Hope Palliative & Hospice Care announced ... group at the Tamarack Senior Living Community in Palatine, IL. ... A.M. on the 3rd Wednesdays of every month. This ... Tamarack Community located at 55 S. Greeley St. Palatine, IL ... there is no cost for the group. , “A ...
(Date:7/13/2014)... (PRWEB) July 13, 2014 Recently, iFitDress.com, ... and women’s special occasion outfits, has added a new ... website. Furthermore, the company has launched a promotion for ... discount. , iFitDress.com is now providing thousands of ... products sell well in Britain, America, France, Italy and ...
(Date:7/12/2014)... July 12, 2014 The Chicken ... the past five years, buoyed by stable demand for ... management system. “Eggs are a relatively affordable staple for ... egg consumption generally grows in line with the size ... McKitterick. Furthermore, demand for new specialty egg products with ...
(Date:7/12/2014)... The report, "Phthalic Anhydride and Derivatives (Plasticizers, Unsaturated Polyester ... – Trends & Forecast to 2018," defines and segments ... volume and value. The report also estimates the demand ... phthalic anhydride is projected to grow from an estimated ... with a CAGR of 5.24% from 2013 to 2018. ...
(Date:7/12/2014)... 2014 Demand Response Management Systems is ... in reducing the imbalance between energy supply and demand. ... been rolled out (due to increasing pressure on the ... helps in controlling residential appliances and thermostats for load ... North American region, and with government mandates and benefits ...
Breaking Medicine News(10 mins):Health News:Hope Hospice Announces Grief Support Group at the Tamarack Senior Living Community 2Health News:New and Beautiful Evening Dresses Unveiled by iFitDress.com 2Health News:Chicken Egg Production in Canada Industry Market Research Report Now Available from IBISWorld 2Health News:Chicken Egg Production in Canada Industry Market Research Report Now Available from IBISWorld 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 4Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 4
... treated with stimulant medications rather than nonstimulant medications ... medications, such as mixed amphetamine salts (MAS) and ... nonstimulant medications such as modafinil. ,This conclusion ... studies representing the past 25 years of research ...
... issued a notice to the Centre asking it to ... implement 27 per cent reservation was taken//. ,With ... Court today decided to examine the government's controversial move ... economically backward classes in higher educational institutions. ...
... junior doctors here who have been protesting the central ... backward classes have sought// President A.P.J. Abdul Kalam's permission ... the president seeking his "permission to immolate themselves", informed ... ,Four of the junior doctors sitting on a ...
... 3 years woke up after being administered a sleeping pill, ... hit the research table for thorough clinical testing. , ... tested on 30 patients during the course of this year, ... of coma. After the initial success, the pill has been ...
... by which 15% of Americans were suffered, was caused ... there's often little left// to do but to suffer ... flatulence make their lives miserable, limiting some of their ... basic of treatments is lifestyle modification instead of taking ...
... the death toll rising to over 3500 and an incalculable ... on scale, Indonesia struggles// to cope with the injured and ... in the south of the city of Yogyakarta which is ... the Friday night. The earthquake left the city in shambles, ...
Cached Medicine News:Health News:Stimulant Medications More Effective In Treating ADHD Than Nonstimulants 2Health News:Supreme Court Verdict Gives Hope to Striking Medicos 2Health News:Silence Puts Comfort For Digestive Syndrome 2Health News:Indonesian Earthquake – Story of Destruction, Death and Disease 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 ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: