Business Medical Dialogues
    • facebook
    • twitter
    Sign in Signup
    • facebook
    • twitter
    Sign in Signup
    • 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
    Sign InRegister
    Business Medical Dialogues
    Sign inRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • News
    • pharma-news
    • Cipla gets USFDA final ...

    Cipla gets USFDA final approval for generic version of Proventil HFA Inhalation Aerosol

    Medical Dialogues BureauBy Medical Dialogues BureauPublished On 2020-04-10T10:00:05+05:30  |  Updated On 2020-04-10T10:00:31+05:30
    Cipla gets USFDA final approval for generic version of Proventil HFA Inhalation Aerosol

    Mumbai: Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, from the United States Food and Drug Administration (US FDA).

    Cipla's Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp's Proventil® HFA Inhalation Aerosol. It is used for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

    According to IQVIA (IMS Health), Proventil® HFA Inhalation Aerosol and its authorized generic equivalent had US sales of approximately $153M for the 12- month period ending February 2020. The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 Billion for the 12-month period ending February 2020.

    Umang Vohra (MD and Global CEO, Cipla Limited) said, "We are pleased to receive the final approval for generic Albuterol MDI from the USFDA. This further strengthens our presence in the US market. Albuterol is the first generic metered dose inhaler of Proventil® HFA Inhalation Aerosol ever approved by FDA in the US and Cipla's first device-based inhalation product in the market. This development reiterates our commitment to strengthening our respiratory franchise and will further solidify our position as a lung leader globally. We will continue to build on our portfolio of drug-device combinations in the respiratory space to serve the unmet needs of our patients across markets."

    Cipla is planning shipments in a staggered manner.

    The company is also ensuring that it does its bit by donating the product in this time of need, the statement said.

    Read also: Cipla completes Phase-3 clinical study for generic version of GSK Advair Diskus

    cipla usfda albuterol-sulfate-inhalation-aerosol proventil-hfa-inhalation-aerosol 

    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

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      Johnson & Johnson Risperdal Lawsuit: US Court Slashes USD 8 Billion Verdict

      Johnson & Johnson Risperdal Lawsuit: US Court Slashes USD 8 Billion Verdict

      Covid-19 Impact: NPPA asks drugmakers to submit availablility data of 58 APIs, details

      Covid-19 Impact: NPPA asks drugmakers to submit availablility data of 58 APIs, details

      Delhi HC directs cashless service to all hospitals: GIPSA stayed on Ophthalmological Society petition

      Delhi HC directs cashless service to all hospitals: GIPSA stayed on Ophthalmological Society...

      Rising prices of hydroxychloroquine raw material forces small scale pharmas in Haridwar to stop production

      Rising prices of hydroxychloroquine raw material forces small scale pharmas in Haridwar to stop...

      Pharmaceuticals safe in PET packaging: High-level committee

      Pharmaceuticals safe in PET packaging: High-level committee

      Union Pharma Secretary Holds video conference with Pharma manufacturers and associations, takes feedback

      Union Pharma Secretary Holds video conference with Pharma manufacturers and associations, takes...

      NPPA fixes prices of 29 formulations under DPCO, check out details

      NPPA fixes prices of 29 formulations under DPCO, check out details

      Top priority on Delivery of Medicines through Speed Post: Minister

      Top priority on Delivery of Medicines through Speed Post: Minister

      View All

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

      Website Last Updated On : 29 March 2022 11:15 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

      This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
      verify here.

      Search only trustworthy HONcode health websites:

      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
      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