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

patic function. Tapentadol should be used with caution in patients with moderate hepatic impairment. NUCYNTA® ER has not been studied in patients with severe hepatic impairment, and use in this population is not recommended.
  • Like other drugs with mu-opioid agonist activity, NUCYNTA® ER may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
  • NUCYNTA® ER should be used with caution in the following conditions: adrenocortical insufficiency (eg, Addison's disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.
  • Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA® ER in pregnant women. NUCYNTA® ER should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus.
  • ADVERSE REACTIONS

    • The most common (>/=10%) adverse reactions were nausea, constipation, headache, dizziness, and somnolence.

    Please see full Product Information for NUCYNTA® at http://www.nucynta.com/

    IMPORTANT SAFETY INFORMATION for NUCYNTA® (tapentadol) immediate release

    CONTRAINDICATIONS

    • Like other drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment. NUCYNTA® is contraindicated in patients who have or are suspected to have paralytic ileus. NUCYNTA® is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOI
      '/>"/>

    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:9/16/2014)... and BOSTON , September 16, 2014 ... Scientific Officer, Fiona Marshall , will give a presentation ... protein-coupled receptors using StaR ®   technology ... in Drug Discovery and Development " virtual symposium run by ... Society. The virtual symposium is on Wednesday, 24 September 2014; ...
    (Date:9/15/2014)... , Sept. 16, 2014 The French ... (HNF) announced today an agreement to collaborate on programs ... support the development of a stronger CMT patient and ... support to several HNF,s initiatives including: , ... the HNF website featuring  HNF newsletters, materials and latest ...
    (Date:9/15/2014)... Sept. 16, 2014  Bayer HealthCare and Orion ... Finland , have begun to enroll ... an investigational oral androgen receptor inhibitor in clinical ... men with castration-resistant prostate cancer who have rising ... metastases. The trial is designed to determine the ...
    Breaking Medicine Technology:Heptares to Present on Structure-Based Drug Design Using G Protein-Coupled Receptors at Inaugural Chemistry & Engineering News Virtual Symposium 2Pharnext and the Hereditary Neuropathy Foundation Collaborate to Increase Awareness of Charcot-Marie-Tooth Disease 2Pharnext and the Hereditary Neuropathy Foundation Collaborate to Increase Awareness of Charcot-Marie-Tooth Disease 3Pharnext and the Hereditary Neuropathy Foundation Collaborate to Increase Awareness of Charcot-Marie-Tooth Disease 4Bayer and Orion Initiate Phase III Trial of ODM-201 in Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer 2Bayer and Orion Initiate Phase III Trial of ODM-201 in Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer 3
    ... Nov. 5, 2010 EnVivo Pharmaceuticals today announced it ... agonist, possesses a novel mechanism not previously seen in ... Acetylcholine (ACh) to enhance cognition. By acting ... makes it possible for smaller amounts of naturally occurring ...
    ... Nov. 5, 2010 Cadence Pharmaceuticals, Inc. (Nasdaq: ... developing and commercializing proprietary product candidates principally for use ... the three and nine months ended September 30, 2010. ... U.S. Food and Drug Administration (FDA) approved OFIRMEV™ (acetaminophen) ...
    Cached Medicine Technology:EnVivo Pharmaceuticals Research Shows EVP-6124 Acts as Acetylcholine Co-Agonist 2EnVivo Pharmaceuticals Research Shows EVP-6124 Acts as Acetylcholine Co-Agonist 3Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results 2Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results 3Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results 4Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results 5Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results 6
    (Date:9/16/2014)... QuickMedical, a national leader in the ... veteran-owned small business has officially launched three new ... Nipro Medical, and CP Medical Sutures. , ... best, most affordable medical equipment and supplies. To ... effort to reach new medical facilities, QuickMedical has ...
    (Date:9/16/2014)... Richmond, VA (PRWEB) September 16, 2014 ... Museum of Virginia this fall. Reflecting on what it ... Ethics: Expanding Community Vision investigates unique and thought-provoking topics. ... people to be inspired to look at their world ... provoking and set the stage for truly enlightening dialogue,” ...
    (Date:9/16/2014)... Today, the Diamond in the Raw Foundation ... held, Sunday, October 19, 2014 at the Skirball Cultural ... show honors the dare-devil stuntwomen of film and television ... Over 12 categories will be recognized in the two-hour ... , Special honors will be given to legendary stuntwomen ...
    (Date:9/16/2014)... N.C. (PRWEB) September 16, 2014 Triad ... President & CEO of Intersil and former President of ... of directors. , “David has extraordinary technology and business ... Triad’s board of directors,” said Lynn Hayden, Triad CEO ... years of analog and mixed signal semiconductor experience to ...
    (Date:9/16/2014)... (PRWEB) September 16, 2014 A peep-toe ... back, bootie, or any other dress shoe) in which ... the toes to show. Peep-toe shoes were popular beginning ... shoes had a brief resurgence in the 1970s/80s, before ... they have enjoyed some popularity again, with variations such ...
    Breaking Medicine News(10 mins):Health News:Expanding Community Vision at the Science Museum of Virginia 2Health News:Hollywood's Action Icon Awards to Honor Legendary Stuntwomen In A Star-Studded Gala and Awards Ceremony 2Health News:David Bell Joins Triad Semiconductor's Board of Directors 2Health News:Nice Peep Toes Are For Sale At Fecbek.com 2
    ... THURSDAY, Dec. 15 (HealthDay News) -- Lack of time is ... suggests that several short intensive workouts a week may help ... regimens. The small, new study found that 30 ... time of 75 minutes a week with warm-up and cool-down ...
    ... -- Nearly 20 million Americans who see a dentist at ... general health care provider, which suggests that dentists could screen ... pressure, diabetes and heart disease, a new study says. ... adults who took part in the 2008 U.S. National Health ...
    ... , THURSDAY, Dec. 15 (HealthDay News) - To catch cervical ... human papillomavirus (HPV) test is the best option for women ... with the more traditional Pap smear resulted in earlier detection ... developing, said study author Dr. Chris Meijer, a professor of ...
    ... researchers at the University of Alberta have discovered a new ... those living with the disease, by using a powerful, triple ... brain tissue. The researchers discovered that iron levels in ... brain that are responsible for relaying messages. High iron levels ...
    ... coffee maker, and the simple quest becomes, well, an ordeal. After ... you finally make a purchase, only to wonder: "Was this the ... Reality check: Is this you? If so, new research ... to make a decision that you,ll be happy with. Joyce ...
    ... (HealthDay News) -- Low levels of iron in the blood ... that form in a vein, according to the results of ... vessel disease. The findings suggest that treating iron deficiency ... (DVT), according to the researchers at Imperial College London in ...
    Cached Medicine News:Health News:Brief, Intense Exercise Lowers Blood Sugar, Small Study Finds 2Health News:Brief, Intense Exercise Lowers Blood Sugar, Small Study Finds 3Health News:Dentists Could Fill Gap in Health Care, Study Says 2Health News:HPV Test Spots Cervical Cancer Earlier Than Pap Smear: Study 2Health News:HPV Test Spots Cervical Cancer Earlier Than Pap Smear: Study 3Health News:Using powerful MRI to track iron levels in brain could be new way to monitor progression of MS 2Health News:Psychology researcher finds that second-guessing one's decisions leads to unhappiness 2Health News:Psychology researcher finds that second-guessing one's decisions leads to unhappiness 3Health News:Low Iron Levels May Increase Blood Clot Risk 2
    The ELISA test is used for detection and semi quantitation of igG antibodies to proteinase 3(PR3) in human sera, as an aid to the diagnosis is of Wegener's granulomatosis....
    ... Acolytes core technology relates to the ultrasensitive ... found in all living cells. ATP ... using bioluminescence. By coupling AK ... via extraction using antibody-coated beads, Acolyte can ...
    ... DYONICS POWERMAX Shaver Handpiece has 25% more ... standard Smith & Nephew handpiece providing optimal ... handling and reduced hand fatigue. ,The forward/reverse ... suction lever are all co-located to allow ...
    ... tailored to individual needs. The pump can ... Indeed a Shaver unit only is featured ... and handpiece.,The REVOLUTION shaver system features a ... progressive motor (up to 4.000 rpm). When ...
    Medicine Products: