LoginRegister

    Alembic Pharma gets USFDA nod for anti-depression drug

    Written by Ruby Khatun Khatun   |  

    New Delhi: Alembic Pharmaceuticals has received the US health regulator's nod for Bupropion Hydrochloride tablets, used for the treatment of the major depressive disorder.


    "The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bupropion Hydrochloride tablets," Alembic Pharmaceuticals said in a BSE filing.

    The approval is for strengths of 75 mg and 100 mg.

    The approved product is therapeutically equivalent to the reference listed drug product (RLD) Wellbutrin tablets of GlaxoSmithKline LLC.

    Quoting IMS December 2017 data, the company said Bupropion Hydrochloride tablets had an estimated market size of USD 37 million.

    The company now has a total of 72 ANDA approvals from the USFDA.
    Abbreviated New Drug ApplicationAlembicAlembic PharmaAlembic PharmaceuticalsANDAanti-depression drugapprovalBupropion Hydrochloride tabletsGlaxoSmithKlinemajor depressive disordersreference listed drug productUnited States Food and Drug AdministrationUSFDAWellbutrin tablets
    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

    Ruby Khatun Khatun
    Ruby Khatun Khatun
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND
      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. © 2020 Minerva Medical Treatment Pvt Ltd

      © 2020 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      sidekick