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|August 07, 2017 8:00 a.m.|
|Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol|
Maintenance Treatment Option Designed to Eliminate the Need for Hand-Breath Coordination During Inhalation
QVAR® RediHaler™ differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated MDI, eliminating the need for hand-breath coordination during inhalation. QVAR® RediHaler™ administers the same active drug ingredient found in QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol, with a different mode of delivery. In addition, QVAR® RediHaler™ is designed to be used without shaking or priming. It should not be used with a spacer or volume holding chamber.
“When working to manage asthma on a daily basis, proper administration
of medication is of paramount importance,” said Dr.
“It’s important that we uncover new opportunities to take longstanding,
clinically effective medications, such as QVAR®, and
incorporate them into device technologies that may help address key
ongoing issues for patients, including inhaler technique,” said
QVAR® MDI with dose counter, the currently available form of
QVAR®, was originally approved by the
This approval is supported by Teva’s clinical development program for QVAR® RediHaler™, which includes data from one Phase I and four Phase III studies that evaluated the safety and efficacy of the product in asthma patients ages four years and older.
Important Limitation of Use: QVAR RediHaler Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
Important Safety Information
Please click here for full Prescribing Information: http://www.qvarredihaler.com/pdf/PI.pdf
A copy may be requested from the US Medical Information Contact
About Teva Respiratory
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 QVAR® RediHaler™, 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:
Teva Pharmaceutical Industries Ltd.