Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • MDTV
    • Anesthesia
    • CTVS
    • Cardiology
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • Diet and nutrition
    • ENT
    • Gastroenterology
    • Health Dialogues
    • Health News today
    • Health Shorts
    • Health Updates
    • Health video of the day
    • Laboratory Medicine
    • Latest Videos
    • Latest Webinars
    • MD shorts
    • Medical News Today
    • Medical Updates
    • Medical Video of the day
    • Medicine
    • Medico Legal Update
    • Nephrology
    • Neurology and Neurosurgery
    • Obstetrics and Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics & Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Top Videos
    • Urology
Medical Dialogues
  • Medical News
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Medical Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
    • Pharmacy Education News
  • MDTV
      • Anesthesia
      • CTVS
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • Diet and nutrition
      • ENT
      • Gastroenterology
      • Health Dialogues
      • Health News today
      • Health Shorts
      • Health Updates
      • Health video of the day
      • Laboratory Medicine
      • Latest Videos
      • Latest Webinars
      • MD shorts
      • Medical News Today
      • Medical Updates
      • Medical Video of the day
      • Medicine
      • Medico Legal Update
      • Nephrology
      • Neurology and Neurosurgery
      • Obstetrics and Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics & Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Top Videos
      • Urology
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Medical Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
  • Case of the Day
  • Editorial
  • Home
  • News
  • Health News
  • Iroko Pharmaceuticals...

Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX™

Meghna A SinghaniaWritten by Meghna A Singhania Published On 2015-10-24T12:36:09+05:30  |  Updated On 24 Oct 2015 7:06 AM GMT
Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX™
  • Facebook
  • Twitter
  • Whatsapp
  • Telegram
  • Linkedin
  • Email
  • koo
  • Facebook
  • Twitter
  • Whatsapp
  • Telegram
  • Linkedin
  • Email
  • koo
  • Facebook
  • Twitter
  • Whatsapp
  • Telegram
  • Linkedin
  • Email
  • koo

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that the United States Food and Drug Administration (FDA) approved VIVLODEX™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain in 5 mg and 10 mg doses administered once daily.1 VIVLODEX is the...

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that the United States Food and Drug Administration (FDA) approved VIVLODEX™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain in 5 mg and 10 mg doses administered once daily.1 VIVLODEX is the first FDA-approved low dose SoluMatrix®meloxicam. This marks an important milestone for the 27 million Americans who live with osteoarthritis.2

VIVLODEX was developed to align with recommendations from FDA and many professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration.3-8 The serious cardiovascular and gastrointestinal adverse events associated with NSAIDs are dose related and risk may occur early in treatment and may increase with duration of use.9-12 Iroko is committed to addressing these FDA safety recommendations by developing NSAIDs that offer effective pain relief at low doses.Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7268051-iroko-fda-approval/

"As recently as July 2015, the FDA announced they would strengthen the existing product label warnings for non-aspirin NSAIDs,13 further highlighting that NSAIDs should be used at the lowest effective dose for the shortest duration to potentially minimize the risk of adverse events," said Dr. Byron Cryer, Associate Dean at The University of Texas Southwestern Medical Center. "Meloxicam is the second most commonly prescribed NSAID in the U.S.14 The approval of VIVLODEX is a welcome option that offers patients an effective, low dose NSAID."

VIVLODEX, developed using proprietary SoluMatrix Fine Particle Technology™, contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.15

"VIVLODEX is Iroko's third FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™," said Osagie Imasogie, Chief Executive Officer and Chairman of the Iroko Board. "Now that we have added a low dose meloxicam product to our growing franchise, we can extend our reach to offer an additional formulation of one of the most commonly used NSAIDs for those affected by osteoarthritis pain,14 a common cause of disability2 and the most common type of arthritis."16

FDA approval of VIVLODEX was supported by data from a Phase 3, multi-center, double-blind, placebo-controlled study of 402 patients, aged 40 and older, with pain due to osteoarthritis of the knee or hip, who were randomized to receive treatment with once-daily VIVLODEX 5 mg, VIVLODEX 10 mg, or placebo over a period of 12 weeks. The VIVLODEX doses studied achieved efficacy at 33 percent lower doses than currently available meloxicam products. The New Drug Application (NDA) also included data from a 12-month open-label safety study that enrolled 600 patients.1,17

"Research has shown that the use of NSAIDs is likely to increase as the U.S. population continues to age and experience painful conditions that are more common among older adults,"16 said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. "Patients with osteoarthritis are often treated with NSAIDs for extended periods to manage their pain. For that reason, this approval is important as we continue to expand the number of low dose NSAID options for patients."

VIVLODEX is indicated for the management of osteoarthritis pain.
FDA Iroko Pharma osteoarthritis VIVLODEX 
Meghna A Singhania
Meghna A Singhania

    Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country.She is a member of the Association of Healthcare Journalists. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

    Show Full Article
    Next Story
    Similar Posts
    India hands over 50-Bedded Friendship Hospital To Tajikistan

    India hands over 50-Bedded Friendship Hospital To Tajikistan

    Walk In Interview At AIIMS Gorakhpur: Vacancies For Senior Resident Post In Various Departments: Check All Details Here

    Walk In Interview At AIIMS Gorakhpur: Vacancies For Senior Resident Post In Various Departments:...

    Tamil Nadu: Newborn girl abducted from Pollachi Government Hospital by two women

    Tamil Nadu: Newborn girl abducted from Pollachi Government Hospital by two women

    Massive 15 kg Ovarian tumour removed from womans abdomen at Patna hospital

    Massive 15 kg Ovarian tumour removed from woman's abdomen at Patna hospital

    ART Fertility Clinics appoints Dr Somesh Mittal as CEO

    ART Fertility Clinics appoints Dr Somesh Mittal as CEO

    UP: 55-year-old Govt Doctor receives transfer letter 13 days after death

    UP: 55-year-old Govt Doctor receives transfer letter 13 days after death

    150 outsourced staff laid off from Delhis RGSSH as all COVID beds lie vacant

    150 outsourced staff laid off from Delhi's RGSSH as all COVID beds lie vacant

    UP: 7 held for smuggling Blood Units mixed with saline water at exorbitant prices

    UP: 7 held for smuggling Blood Units mixed with saline water at exorbitant prices

    Karnataka: Doctor duped of Rs 1.16 crore on pretext of MBBS admission for son in M.S. Ramaiah Medical College, 5 accused held

    Karnataka: Doctor duped of Rs 1.16 crore on pretext of MBBS admission for son in M.S. Ramaiah...

    Karnataka: Govt to set up 438 Namma Clinics

    Karnataka: Govt to set up 438 Namma Clinics

    Odisha: VIMSAR recruits 26 Assistant Professors

    Odisha: VIMSAR recruits 26 Assistant Professors

    IIM-Bangalore launches 1-year certificate programme in Hospital Management

    IIM-Bangalore launches 1-year certificate programme in Hospital Management

    Govt appoints Radiologist, Paediatrician, Orthopaedic surgeon at Keylong district hospital

    Govt appoints Radiologist, Paediatrician, Orthopaedic surgeon at Keylong district hospital

    Editorial

    Propranolol and essential tremors: A critical review

    Propranolol and essential tremors: A critical review

    Safeguarding Mental Health of Doctors & How They Can Prevent a Burnout

    Safeguarding Mental Health of Doctors & How They Can Prevent a Burnout

    Analyzing the Role of Levofloxacin in Urinary Tract Infections-A review

    Analyzing the Role of Levofloxacin in Urinary Tract Infections-A review

    Management of Allergic Rhinitis during COVID-19 Pandemic

    Management of Allergic Rhinitis during COVID-19 Pandemic

    Role of Probiotics in recurrent bacterial vaginosis: A review

    Role of Probiotics in recurrent bacterial vaginosis: A review

    View All

    Journal Club Today

    Spinal fractures in the elderly can be prevented with simple X-rays

    Spinal fractures in the elderly can be prevented with simple X-rays

    View All

    Health News Today

    Health Bulletin 4/July/2022

    Health Bulletin 4/July/2022

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok
    X
    X