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
    • Editors Pick
    • Cipla gets USFDA...

    Cipla gets USFDA approval for generic equivalents of Vazculep, Aromasin

    Written by Ruby Khatun Khatun Published On 2018-05-03T10:10:43+05:30  |  Updated On 3 May 2018 10:10 AM IST
    Cipla gets USFDA approval for generic equivalents of Vazculep, Aromasin

    New Delhi: Drug major Cipla has received final approval from the US health regulator for the generic equivalent of Avadel's Vazculep, West Ward Pharm Corp's Phenylephrine Hydrochloride injection and Pfizer's Aromasin.


    In a regulatory filing, Cipla said "it has received final approval for its abbreviated new drug application (ANDA) for Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) pharmacy bulk package, Phenylephrine Hydrochloride Injection USP, 10 mg/mL single dose vial and exemestane tablets, 25 mg from the United States Food and Drug Administration (USFDA)".


    Cipla said Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) pharmacy bulk package, is an AP-rated generic equivalent of Avadel's Vazculep and is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.


    Cipla's Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single-Dose Vial, is an AP-rated generic equivalent of West Ward Pharm Corp's Phenylephrine Hydrochloride Injection, 10 mg/mL, and is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.


    Cipla's exemestane tablets, 25mg, is an AB-rated generic equivalent of Pfizer's Aromasin and is indicated for the treatment of certain types of breast cancer in postmenopausal women.


    All these products will be available for shipping in the near future.


    Citing IQVIA (IMS) Health data, Cipla said Vazculep and generic equivalents had US sales of approximately USD 56 million for the 12-month period ending February.


    Aromasin and generic equivalents had US sales of approximately USD 77 million for the 12-month period ending February 2018, according to IMS Health, it added.


    Cipla said the products are manufactured at the company's Goa plant.

    Abbreviated New Drug ApplicationanesthesiaapprovalAromasinAvadelCiplafinal approvalgeneric equivalentsPfizerPhenylephrine Hydrochloride injectionUnited States Food and Drug AdministrationUSFDAVazculepWest Ward Pharm Corp
    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

      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