FDA approves ProAir Digihaler (albuterol sulfate) as the first and only digital inhaler with built-in sensors

Teva Pharmaceutical Industries Ltd. announced recently 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.

“This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio.

“Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir ® Digihaler™. The digital technology built into ProAir ® Digihaler™ provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.”

ProAir ® Digihaler™ 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 of ProAir ® Digihaler™ 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.

“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. That’s what makes a product like this so important to doctor-patient discussions,” said Tushar Shah, M.D., Global Head of Specialty Clinical Development & Medical Affairs at Teva Pharmaceuticals. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.”

Approved uses

ProAir ® Digihaler™ (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:

treat or prevent bronchospasm in people who have reversible obstructive airway disease

prevent exercise-induced bronchospasm

ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.

Important safety information

Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure

Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems

have high blood pressure (hypertension)

have convulsions (seizures)

have thyroid problems

have diabetes

have low potassium levels in your blood

are pregnant or planning to become pregnant

are breastfeeding or planning to breastfeed

Tell your healthcare provider about all the medicines you take, especially:

other inhaled medicines or asthma medicines

beta blocker medicines

diuretics

digoxin

monoamine oxidase inhibitors

tricyclic antidepressants

Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider

Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so

ProAir Digihaler may cause serious side effects, including:

worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away.

This is more likely to happen with your first use of a new asthma inhalation medicine

heart problems, including faster heart rate and higher blood pressure

possible death in people with asthma who use too much ProAir Digihaler

allergic reactions. Call your healthcare provider right away if you have the following symptoms of an allergic reaction:

itchy skin

swelling beneath your skin or in your throat

rash

worsening trouble breathing

changes in laboratory blood values (sugar, potassium)

The most common side effects of ProAir Digihaler include:

back pain

body aches and pain

upset stomach

sinus headache

urinary tract infection

your heart feels like it is pounding or racing (palpitations)

chest pain

fast heart rate

shakiness

nervousness

headache

dizziness

sore throat

runny nose

These are not all of the possible side effects of ProAir Digihaler.

FDA approves ProAir Digihaler (albuterol sulfate) as the first and only digital inhaler with built-in sensors

Teva Pharmaceutical Industries Ltd. announced recently 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. This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology, said Sven Dethlefs, Executive Vice President, Global Marketing Portfolio. Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir Digihaler. The digital technology built into ProAir Digihaler provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management. ProAir Digihaler 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 of ProAir Digihaler 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. One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. Thats what makes a product like this so important to doctor-patient discussions, said Tushar Shah, M.D., Global Head of Specialty Clinical Development Medical Affairs at Teva Pharmaceuticals. Offering a tool that enables doctors to see data on their patients inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness. Approved uses ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to: treat or prevent bronchospasm in people who have reversible obstructive airway disease prevent exercise-induced bronchospasm ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine. Important safety information Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you: have heart problems have high blood pressure (hypertension) have convulsions (seizures) have thyroid problems have diabetes have low potassium levels in your blood are pregnant or planning to become pregnant are breastfeeding or planning to breastfeed Tell your healthcare provider about all the medicines you take, especially: other inhaled medicines or asthma medicines beta blocker medicines diuretics digoxin monoamine oxidase inhibitors tricyclic antidepressants Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so ProAir Digihaler may cause serious side effects, including: worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new asthma inhalation medicine heart problems, including faster heart rate and higher blood pressure possible death in people with asthma who use too much ProAir Digihaler allergic reactions. Call your healthcare provider right away if you have the following symptoms of an allergic reaction: itchy skin swelling beneath your skin or in your throat rash worsening trouble breathing changes in laboratory blood values (sugar, potassium) The most common side effects of ProAir Digihaler include: back pain body aches and pain upset stomach sinus headache urinary tract infection your heart feels like it is pounding or racing (palpitations) chest pain fast heart rate shakiness nervousness headache dizziness sore throat runny nose These are not all of the possible side effects of ProAir Digihaler.