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FDA nod for breath-actuated QVAR inhaler

by JMC on August 7, 2017

The US Food and Drug Administration (FDA) has approved QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy.

This product, expected to become commercially available in both 40mcg and 80mcg strengths to patients by prescription during the first quarter of 2018, is from Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA). It administers the same active drug ingredient found in QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol, with a different mode of delivery.

QVAR RediHaler, which is not indicated for the relief of acute bronchospasm, 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.

Warner Carr, associate medical director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group in Mission Viejo, California, said: “When working to manage asthma on a daily basis, proper administration of medication is of paramount importance.

“However, research has indicated that approximately 76% of patients still struggle to use their MDI inhalers correctly, thus placing them at increased risk for asthma exacerbations. From a clinical perspective, QVAR RediHaler is a much-needed treatment option for these patients who may be experiencing continued difficulty with hand-breath coordination.”

QVAR MDI with dose counter, the currently available form of QVAR, was originally approved by the FDA in 2014. Teva plans to discontinue sales of that formulation upon the launch of QVAR RediHaler in the first quarter of 2018.

Source: FDA nod for breath-actuated QVAR inhaler

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