Navigation Links
Supplemental New Drug Application Submitted to FDA for NUCYNTA® ER (Tapentadol) Extended-Release Tablets for Diabetic Peripheral Neuropathic Pain
Date:10/31/2011

course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA® ER should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.
  • Tapentadol is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty.
  • Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
  • NUCYNTA® ER can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addiction, since use of mu-opioid agonist analgesic products carries the risk of addiction even under appropriate medical use.
  • Drug abusers may attempt to abuse NUCYNTA® ER by crushing, chewing, snorting, or injecting the product. These practices may result in the uncontrolled delivery of NUCYNTA® ER and pose a significant risk to the abuser that could result in overdose and death.
  • NUCYNTA® ER may cause severe hypotension. Patients at higher risk of hypotension include those with hypovolemia or those taking concurrent products that compromise vasomotor tone (eg, phenothiazines, general anesthetics).
  • Patients should be cautioned that NUCYNTA® ER may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected, especially at the beginning of treatment, at any change of dosa
    '/>"/>

  • SOURCE Janssen Pharmaceuticals Research & Development
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

    Related medicine technology :

    1. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
    2. ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
    3. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
    4. Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
    5. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
    6. CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
    7. Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
    8. FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
    9. Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
    10. Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
    11. 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
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:9/2/2014)... , Sept. 2, 2014 Reportbuyer.com ... Global Markets and Technologies for Molecular Imaging ... STUDY GOALS AND OBJECTIVES The objectives of ... at molecular imaging devices used for diagnostic purposes, ... market and all possible market segments as well ...
    (Date:9/2/2014)... 2, 2014 Reportbuyer.com has added a ... Global Markets for Services and Devices ... Bariatric surgery or weight loss surgery is a ... processes that deal with the surgical treatment of ... (endoluminal) and performed in both open and laparoscopic ...
    (Date:9/2/2014)... , Sept. 2, 2014 Astellas has appointed ... intellectual property (IP) in the Americas. Kellerman will report ... & general counsel at Astellas. In his new role, ... partner with the business and manage the region,s intellectual ... "I am very pleased to welcome Jim ...
    Breaking Medicine Technology:Global Markets and Technologies for Molecular Imaging Devices 2Global Markets and Technologies for Molecular Imaging Devices 3Global Markets and Technologies for Molecular Imaging Devices 4Global Markets and Technologies for Molecular Imaging Devices 5Global Markets and Technologies for Molecular Imaging Devices 6Global Markets and Technologies for Molecular Imaging Devices 7Global Markets and Technologies for Molecular Imaging Devices 8Global Markets and Technologies for Molecular Imaging Devices 9Global Markets and Technologies for Molecular Imaging Devices 10Global Markets and Technologies for Molecular Imaging Devices 11Global Markets and Technologies for Molecular Imaging Devices 12Global Markets and Technologies for Molecular Imaging Devices 13Global Markets and Technologies for Molecular Imaging Devices 14Global Markets and Technologies for Molecular Imaging Devices 15Global Markets and Technologies for Molecular Imaging Devices 16Global Markets and Technologies for Molecular Imaging Devices 17Global Markets and Technologies for Molecular Imaging Devices 18Global Markets and Technologies for Molecular Imaging Devices 19Global Markets and Technologies for Molecular Imaging Devices 20Global Markets and Technologies for Molecular Imaging Devices 21Global Markets and Technologies for Molecular Imaging Devices 22Global Markets and Technologies for Molecular Imaging Devices 23Global Markets and Technologies for Molecular Imaging Devices 24Global Markets and Technologies for Molecular Imaging Devices 25Bariatric Surgery: Global Markets for Services and Devices 2Bariatric Surgery: Global Markets for Services and Devices 3Bariatric Surgery: Global Markets for Services and Devices 4Bariatric Surgery: Global Markets for Services and Devices 5Bariatric Surgery: Global Markets for Services and Devices 6Bariatric Surgery: Global Markets for Services and Devices 7Bariatric Surgery: Global Markets for Services and Devices 8Bariatric Surgery: Global Markets for Services and Devices 9Bariatric Surgery: Global Markets for Services and Devices 10Bariatric Surgery: Global Markets for Services and Devices 11Bariatric Surgery: Global Markets for Services and Devices 12
    ... NATICK, Mass. and BARCELONA, Spain, May 20 Boston ... results from an analysis of economic and quality of ... SYNTAX trial. The results found that percutaneous coronary ... System was consistently associated with fewer patient hospital days ...
    ... suggest pirfenidone may provide meaningful clinical benefit in IPF ... safety reported -- Conference Call and Webcast at 9 ... 19 InterMune, Inc. (Nasdaq: ITMN ) ... studies evaluating pirfenidone in patients with idiopathic pulmonary fibrosis ...
    Cached Medicine Technology:SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(R) Stent System More Cost Effective Than Bypass Surgery in Patients With Complex Coronary Artery Disease 2SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(R) Stent System More Cost Effective Than Bypass Surgery in Patients With Complex Coronary Artery Disease 3SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(R) Stent System More Cost Effective Than Bypass Surgery in Patients With Complex Coronary Artery Disease 4SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(R) Stent System More Cost Effective Than Bypass Surgery in Patients With Complex Coronary Artery Disease 5Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 2Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 3Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 4Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 5Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 6Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 7Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 8Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 9Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 10Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 11Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) 12
    (Date:9/2/2014)... News) -- Complications are rare among breast cancer ... study indicates. However, the researchers did find ... slightly higher risk for certain complications than a ... 18,000 breast cancer patients who had a single ... reconstruction and were followed for 30 days after ...
    (Date:9/2/2014)... 2, 2014 In a large population-based study ... that mild cognitive impairment (MCI) occurred twice more ... 2. Interestingly, this strong association was only observed ... participants (66-80 years) the association vanished. This study ... Disease . , The concept of MCI describes ...
    (Date:9/2/2014)... (PRWEB) September 02, 2014 Medex ... location of their corporate headquarters in Coral Springs, Fla. ... have exceeded our business development objectives for the 2014 ... Neil Herbst. “Our industry has requested a higher level ... utilization reviews. Medex has delivered, and the industry has ...
    (Date:9/2/2014)... Kathleen Doheny HealthDay ... The U.S. obesity epidemic is a driving force behind the ... study. Researchers looked at data from five national surveys ... increase in diabetes over time could be explained by factors ... U.S. adults. The investigators found that the prevalence of ...
    (Date:9/2/2014)... -- Melatonin supplements did not reduce delirium in seniors ... found. Many older hospital patients experience the sudden, ... their normal sleep-wake cycle. A lack of the hormone ... but there has been little research into whether melatonin ... 378 patients, average age 84, who had hip fracture ...
    Breaking Medicine News(10 mins):Health News:Complication Rates Low With Mastectomy, Breast Reconstruction: Study 2Health News:Diabetes mellitus and mild cognitive impairment: Higher risk in middle age? 2Health News:Medex Analytic Services Announces New Location for Corporate Headquarters 2Health News:Obesity Fueling Rise in Diabetes Rates, Study Finds 2Health News:Obesity Fueling Rise in Diabetes Rates, Study Finds 3
    ... Minn. -- A Mayo Clinic study of a drug that ... demonstrates that the drug may also be effective in treating ... The study, which was done in mouse models, is featured ... , The National Cancer Institute reports that of 240,510 ...
    ... physicians not to disclose bad news to ill loved ... be truthful to the patient with the familys belief ... more successfully manage these conflicts, researchers at the University ... at Stanford University, have developed an approach based on ...
    ... is overweight when she becomes pregnant, the probability is ... when he/she reaches school age, according to a new ... Alina Rodriguez at Uppsala University in collaboration with international ... of Obesity. , The study, comprising more than 12,500 ...
    ... Global Med Technologies(R),Inc. (OTC Bulletin Board: GLOB), ... presenting at the Acumen Biofin,Rodman & Renshaw 9th ... the New York Palace Hotel in New York ... Tuesday, November 6th, at 11:15 a.m. EST, Dr. ...
    ... Technologies,Corporation (Nasdaq: DVAX ) announced today Michael S. ... overview of the,company at two investor conferences in New ... at the CIBC World Markets 18th Annual,Healthcare Conference on ... PT). In addition, Ostrach will present at the Acumen ...
    ... Arete Therapeutics Inc. today,announced the initiation of ... compound,AR9281, for the treatment of hypertension. AR9281 is ... a novel target,for the treatment of hypertension. The ... and will evaluate the safety, tolerability,pharmacokinetics and pharmacodynamics ...
    Cached Medicine News:Health News:Mayo Clinic study shows drug could effectively treat, prevent the spread of breast cancer 2Health News:Mayo Clinic study shows drug could effectively treat, prevent the spread of breast cancer 3Health News:Don't tell mother she has cancer 2Health News:Overweight mothers run greater risk of having hyperactive children 2Health News:Global Med Technologies(R) to Present at Rodman & Renshaw 9th Annual Healthcare Conference 2Health News:Dynavax to Present at CIBC World Markets and Acumen BioFin Rodman and Renshaw Healthcare Conferences 2Health News:Arete Therapeutics Initiates Phase 1 Clinical Trial For AR9281 as a First-in-Class Antihypertensive Agent 2Health News:Arete Therapeutics Initiates Phase 1 Clinical Trial For AR9281 as a First-in-Class Antihypertensive Agent 3
    ... Spinal Implant system. Material that has a ... bone. The result is an implant that ... support, while optimizing the fusion environment through ... anatomic design with 5 and 10 degrees ...
    Cervical distraction screw retractor blade with Casper style distractor...
    ... Panther Retractor is two system in ... use for all cervicle spine retraction ... aluminium facilitate soft tissue retraction and ... intra-operative imaging with minimal interference. Two ...
    Cloward cervical retractor. Size 18 mm....
    Medicine Products: