Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

First and Only Digital Inhaler With Built-In Sensors Approved by FDA

By Teva Pharmaceutical Industries | December 26, 2018

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD.

ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older.

It contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth wireless technology so patients can review their data over time, and if desired, share it with their healthcare professionals.

The approval is based on the review of a supplemental new drug application (sNDA) submitted by Teva to the FDA. ProAir Digihaler combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app.

It will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with healthcare systems and in limited geographies, in order to gather real-world experience, according to Teva. A national launch is planned for 2020.

(Source: Teva Pharmaceutical Industries Ltd.)

Related Articles Read More >

This is a Hemco marketing image of its MicroFlow self-contained workstation.
Hemco highlights its self-contained workstations
Great Point Partners logo.
Great Point Partners acquires majority stake in Eutecma to fuel sustainable cold chain growth
Moving toward the autonomous lab and what’s possible today
Female worker at pharmaceutical factory operating control panel of the pharmaceutical machine.
How real-time sensors and data-savvy can cut energy waste in pharma
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE