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:1/23/2015)... , Jan. 23, 2015  Pete Rose, baseball,s all-time hits leader, ... arthritis pain reliever Myoflex, Ducere Pharma has announced. ... are excited to have him on board with Myoflex," said ... is a legendary player who is known across all generations. ...
(Date:1/23/2015)... LAS VEGAS , Jan. 23, 2015 Cord Blood ... CBAI ) ("CBAI" or the "Company")  filed a Preliminary Proxy ... ( www.sec.gov ) today, and provides an update for shareholders ... authorized shares is requested. Dear Shareholders, ...
(Date:1/23/2015)... , January 23, 2015 Heptares Therapeutics, ... delighted to announce that the Malcolm Campbell Memorial ... (Vice President of Chemistry), Fiona Marshall (Chief ... Executive Officer and co-founder) for the seminal contributions to GPCR ...
Breaking Medicine Technology:Pete Rose bets on Myoflex to relieve aches and pains 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4
... 2011 Kensey Nash Corporation (Nasdaq: KNSY ) ... (SBIR) grant from the National Institutes of Health (NIH). ... $1.9 million Phase II SBIR grant to further investigate the ... repair procedures.  The Company will develop and evaluate the ability ...
... Nov. 7, 2011 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Inc. (NYSE ... specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine ... announced that the earnings conference call for the first ... will be held at 8:30 a.m. Eastern Time on ...
Cached Medicine Technology:TPI to Host First Quarter Fiscal Year 2012 Earnings Conference Call on Monday, November 14, 2011 at 8:30 a.m. ET 2
(Date:1/22/2015)... the premier women’s dress supplier, has recently released its ... of AngelWeddingDress.com to find more details. , Many ... a bridal party. AngelWeddingDress offers a variety of gorgeous ... wedding dresses are specially designed for 2015. , AngelWeddingDress ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David ... Show to bestow a Juvent Sports Achievement award upon ... McKitrick. The award commemorated and congratulated McKitrick for her ... won her first amateur tournament in 1979 and most ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Thousand of ... Medical Care recalled its GranuFlo and NaturaLyte dialysis concentrates ... underway in U.S. District Court, District of Massachusetts, Bernstein ... 20th, the Court has remanded a case filed by ...
(Date:1/22/2015)... Oceanside,CA (PRWEB) January 22, 2015 For over 20 ... the Oceanside and Vista area has treated just about ... other personal injury circumstances. And for those same twenty-plus years, ... victims of all those injuries with the best possible doctor. ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Joan Lunden, ... keynote speaker at the upcoming 32nd Annual Miami ... Physicians’ Education Resource®, LLC (PER®) , shares that ... have gone undetected if she had not followed up ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6
... U.S. Secretary of Labor Elaine L. Chao today announced the ... on Occupational Safety and Health (NACOSH). The committee, established ... the Secretaries of labor and health and human services on ... , "We appreciate the advisory committee members, willingness ...
... Henry Mayo Newhall Memorial,Hospital in Valencia, California, has received ... $300 million master plan. The plan calls for the,development ... buildings, plus a,helipad and new parking structures. , ... not-for-profit hospital has seen tremendous growth in,the surrounding Santa ...
... UPTON, NY - Four physicists at the U.S. Department ... U.S. Patent No. 7,432,516 B2 for the design of ... proton radiation to cancerous tumors with minimal damage to ... precise and less costly than existing proton-therapy systems, potentially ...
... Ohio and PHOENIX, Nov. 25 There is a new,Internet ... the family,s basic need to stay informed, it allows,long-term care ... web page, by email and text message without families having,to ... Too much to do and too little ...
... The latest innovations in fluoroscopy, interventional radiology, and digital ... , MALVERN, Pa., Nov. 25 ... ) covers the entire spectrum of radiology, from fluoroscopy ... Scientific Assembly and Annual Meeting of the Radiological Society ...
... (Nasdaq: IDIX ) announced today that Idenix management ... Wednesday, December 3, 2008 at 4:30p.m. ET at The New ... , The live and archived webcast of ... in the Idenix Investor Center at www.idenix.com . ...
Cached Medicine News:Health News:U.S. Labor Secretary Elaine L. Chao announces new membership of OSHA advisory committee 2Health News:U.S. Labor Secretary Elaine L. Chao announces new membership of OSHA advisory committee 3Health News:Henry Mayo Newhall Memorial Hospital to Proceed With Master Plan 2Health News:Henry Mayo Newhall Memorial Hospital to Proceed With Master Plan 3Health News:Physicists receive patent for improved cancer therapy device 2Health News:Physicists receive patent for improved cancer therapy device 3Health News:New Internet Service Delivers Relief to Families of Those in Long-Term Care 2Health News:Siemens Demonstrates Flexibility, Enhanced Workflow and Imaging Excellence 2Health News:Siemens Demonstrates Flexibility, Enhanced Workflow and Imaging Excellence 3Health News:Siemens Demonstrates Flexibility, Enhanced Workflow and Imaging Excellence 4Health News:Siemens Demonstrates Flexibility, Enhanced Workflow and Imaging Excellence 5Health News:Siemens Demonstrates Flexibility, Enhanced Workflow and Imaging Excellence 6
Individually, self-contained, stackable drawers....
Shandon Wooden Slide File Storage Box...
Modular Specimen Filing System has five cells that can hold either slides or tissue cassettes....
... expanded database containing over 330 species ... VITEK 2 Compact offers enhanced identification ... time (2 to 14 hours), it ... that contaminate production areas and final ...
Medicine Products: