Teva Announces FDA Approval of QNASLTM, a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis

Teva Pharmaceutical

Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved QNASLTM Nasal Aerosol, a new, “dry” nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. The product is expected to be available by prescription in April 2012 and will be the first marketed nonaqueous or “dry” nasal aerosol in a product category that reports annual sales of $2.5 billion.1 QNASLTM is delivered as a once-daily, pressurized, HFA-propelled nonaqueous aerosol that is environmentally friendly2 and offers a built-in dose counter. “There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies,” said Gary N. Gross, MD, FACAAI, practicing allergist and co-founder of the Dallas Asthma and Allergy Center. “The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery.” The approval of QNASLTM Nasal Aerosol is based on a comprehensive clinical development program that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis (

) and perennial allergic rhinitis (

) in adolescent and adult patients 12 years of age and older. The safety and efficacy of QNASLTM Nasal Aerosol was demonstrated in four, Phase III randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials. In these trials, patients received QNASLTM 320 mcg once-daily administered as two sprays in each nostril.