X
ACHEMA MIDDLE EAST 2026
Pharma Advancement
DDF Summit 2025
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    idiopathic pulmonary fibrosis

    US FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis

    Tissue Repair Drug

    FDA Clears Tissue Repair Drug AD-NP1 For Clinical Trials

    FastTrack Review

    US FDA Launches Fast-Track Review Scheme for Generic Drugs

    AI Based Drug Discovery

    Bristol Myers, Takeda, Astex to Back AI Based Drug Discovery

    wearable drug delivery devices

    Wearable Drug Delivery Devices for On-Demand Care

    biologic drug formulation stability

    Breakthroughs in Biologic Drug Formulation Stability

    high volume injectable formulations

    Overcoming Challenges in High-Volume Injectable Formulations

    lipid nanoparticles in RNA therapies

    Lipid Nanoparticles in RNA and Gene Therapies

    Breast Cancer Therapy

    US FDA Approves Breast Cancer Therapy Inluriyo by Eli Lilly

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    idiopathic pulmonary fibrosis

    US FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis

    Tissue Repair Drug

    FDA Clears Tissue Repair Drug AD-NP1 For Clinical Trials

    FastTrack Review

    US FDA Launches Fast-Track Review Scheme for Generic Drugs

    AI Based Drug Discovery

    Bristol Myers, Takeda, Astex to Back AI Based Drug Discovery

    wearable drug delivery devices

    Wearable Drug Delivery Devices for On-Demand Care

    biologic drug formulation stability

    Breakthroughs in Biologic Drug Formulation Stability

    high volume injectable formulations

    Overcoming Challenges in High-Volume Injectable Formulations

    lipid nanoparticles in RNA therapies

    Lipid Nanoparticles in RNA and Gene Therapies

    Breast Cancer Therapy

    US FDA Approves Breast Cancer Therapy Inluriyo by Eli Lilly

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Europe

European Commission grants marketing approval for Teva’s DuoResp Spiromax

Yuvraj_pawp by Yuvraj_pawp
30th April 2014
in Europe, News

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Teva Pharmaceutical has obtained marketing authorisation approval from European Commission for its DuoResp Spiromax for treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta(2) adrenoceptor agonist is appropriate.

DuoResp Spiromax, a multi-dose dry-powder inhaler, contains a fixed-dose combination of budesonide and formoterol fumarate dehydrate.

Budesonide is an inhaled corticosteroid indicated for the treatment of the underlying inflammation in asthma and COPD.

Formoterol fumarate dehydrate is a rapid-acting and long-lasting beta(2) agonist for the relief of bronchoconstriction in asthma and COPD.

According to Teva, DuoResp Spiromax has been demonstrated to be therapeutically equivalent to the budesonide/formoterol combination.

Teva has designed the Spiromax inhaler by considering patient inhalation challenges not in terms of human error, but as a design problem to be solved. Using a unique technology, the inhaler delivers consistent, effective and accurate dose.

Teva claims that the ease-of-use Spiromax inhaler provides consistent delivery from the first to the last dose with three simple steps, including open, breathe and close.

“This is a major advance in inhalers, the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups.”

Teva Global Specialty Medicines president and CEO Dr Rob Koremans said: “This is a major advance in inhalers, the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups.

“It is widely accepted that poor or inadequate inhaler technique not only negatively impacts treatment adherence, but means that patients do not obtain the full benefit from their medication.

“We are extremely proud of Spiromax. Our innovative approach to the development of the product means that it offers the key features required for an ideal inhaler.

“DuoResp Spiromax provides a valuable addition to currently available inhalation devices for the treatment of asthma and COPD. It is the first and important milestone in the rollout of our respiratory portfolio in Europe.”

Two European Phase III trials are currently comparing the benefits of DuoResp Spiromax and a budesonide/formoterol multi-dose dry powder inhaler in patients with persistent asthma are ongoing. Results of the two trials are expected to be announced later this year.

In February, The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorisation for Teva’s DuoResp Spiromax inhalation powder

Tags: Europe
Previous Post

Janssen's type 2 diabetes drug Vokanamet gets European Commission approval in EU

Next Post

UF Health successfully implements genomic medicine program

Related Posts

idiopathic pulmonary fibrosis
Americas

US FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis

9th October 2025
Tissue Repair Drug
Clinical Trials

FDA Clears Tissue Repair Drug AD-NP1 For Clinical Trials

7th October 2025
FastTrack Review
Americas

US FDA Launches Fast-Track Review Scheme for Generic Drugs

7th October 2025
AI Based Drug Discovery
Drug Development

Bristol Myers, Takeda, Astex to Back AI Based Drug Discovery

1st October 2025
API Manufacturing Facility
Americas

AbbVie Launches New API Manufacturing Facility in Illinois

1st October 2025
U.S. manufacturing
Americas

Amgen to Expand U.S. Manufacturing with $650M Investment

30th September 2025
Next Post

UF Health successfully implements genomic medicine program

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In