FDA approves QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol to treat asthma. Teva Pharma

Teva Pharmaceutical Industries Ltd. announced that the FDA has approved QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older. QVAR RediHaler is not indicated for the relief of acute bronchospasm.

The product is expected to become commercially available in both 40mcg and 80mcg strengths to patients by prescription during the first quarter of 2018. 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.

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 this current QVAR MDI formulation upon the launch of QVAR RediHaler in the first quarter of 2018. Patients and caregivers are encouraged to speak with a healthcare professional about how this transition may impact their current treatment plan.