Teva Secures FDA Approval on QVAR RediHaler Inhalation Aerosol

American depository shares of Teva Pharmaceutical Industries were down almost 4% Monday morning although the company said the U.S. Food and Drug Administration (FDA) approved its QVAR RediHaler 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 40 mcg and 80 mcg strengths to patients by prescription during Q1. 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 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.

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