FDA Approves Qvar With Dose Counter

Teva announced that the FDA has approved Qvar (beclomethasone dipropionate HFA) with a dose counter for the ongoing treatment of asthma as a preventative therapy in patients ≥5 years of age.

In 2003, the FDA issued guidance recommending that metered-dose inhalers (MDIs) should have a clear indication of when an MDI is approaching the end of its recommended number of actuations, as well as when it has reached or exceeded that number.

Qvar is already approved for the maintenance treatment of asthma as prophylactic therapy in patients ≥5 years of age. It is also indicated for asthma patients who require systemic corticosteroid administration, where adding Qvar may reduce or eliminate the need for the systemic corticosteroids.

Qvar with a dose counter will be available in 40mcg and 80mcg strengths. The new product is expected to launch later this year.

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