Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Latest News
    • Alembic Pharma gets...

    Alembic Pharma gets tentative nod from USFDA for Febuxostat

    Written by savita thakur thakur Published On 2016-07-05T15:14:50+05:30  |  Updated On 5 July 2016 3:14 PM IST

    New Delhi : Alembic Pharmaceuticals has received tentative approval from the US health regulator for Febuxostat tablets used for treatment of hyperuricemia in patients of gout.


    "The company has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Febuxostat tablets, 40 mg and 80 mg," Alembic Pharmaceuticals said in a BSE filing.


    The product is therapeutic equivalent to the reference listed drug Uloric tablets, 40 mg, 80 mg of Takeda Pharmaceuticals USA Inc, it added.


    Alembic Pharmaceuticals said it has settled the case with Takeda and will launch its generic as per the terms of settlement.


    The tablets, indicated for chronic management of hyperuricemia in patients of gout, had an estimated market size of USD 430 million for 12 months to December 2015.


    The company has 48 ANDA approvals (43 final and 5 tentative from the USFDA.


    Alembic stock was trading 0.57 per cent up at Rs 582.75 in the morning trade on BSE.

    Abbreviated New Drug ApplicationAlembic PharmaANDAapprovalFebuxostatTakedatentative nodtreatment of hyperuricemiaUS Food & Drug AdministrationUSFDA
    Source : PTI

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    savita thakur thakur
    savita thakur thakur
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      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