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Press release content from BusinessWire. The AP news staff was not involved in its creation.
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Press release content from BusinessWire. The AP news staff was not involved in its creation.

Teva Announces FDA Approval of First and Only Digital Inhaler with Built-In Sensors – ProAir® Digihaler™ (albuterol sulfate 117 mcg) Inhalation Powder

December 21, 2018 GMT

JERUSALEM--(BUSINESS WIRE)--Dec 21, 2018--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today 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.

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“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.

“There are 25 million Americans living with asthma 1, many of whom use inhalers as part of their treatment regimen. Despite advancements in care over the years, we know that many are using their rescue medications incorrectly 2 or too often 3,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “The FDA approval of ProAir ® Digihaler ™ is significant because it may help patients track their inhaler usage and provide data that can be used to work more closely with their HCPs on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”

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.”

ProAir ® Digihaler™ 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. A national launch is planned for 2020. For more information, visit www.ProAirDigihaler.com.

APPROVED USES

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

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

Please read the full Prescribing Information.

About Teva

Teva Pharmaceutical Industries Ltd. is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

Teva Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding ProAir ® Digihaler™, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Teva Pharmaceutical Industries Ltd. is under license. Other trademarks and trade names are those of their respective owners.

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CONTACT: IR Contacts:Kevin C. Mannix

United States

(215) 591-8912Ran Meir

United States

972 (3) 926-7516PR Contacts:Yonatan Beker

Israel

972 (54) 888-5898Doris Saltkill

United States

(913) 777-3343

KEYWORD: MIDDLE EAST ISRAEL

INDUSTRY KEYWORD: TECHNOLOGY HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES MOBILE/WIRELESS FDA

SOURCE: Teva Pharmaceutical Industries Ltd.

Copyright Business Wire 2018.

PUB: 12/21/2018 03:19 PM/DISC: 12/21/2018 03:18 PM

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