FDA approves QNASL for Allergic Rhinitis in Children-Teva

Teva Pharmaceutical Industries Ltd.announced that the FDA approved QNASL� (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age.

FDA approval was based on data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL 40 mcg in children (ages 4-11) with AR. Data demonstrated that once-daily treatment with QNASL 40 mcg provided significant nasal allergy symptom relief in children with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in comparison to placebo. In all three studies, the safety profile of QNASL 40 mcg was similar to that of placebo and the most common adverse events were nosebleeds and ulcers, which is consistent with those seen in previous clinical studies of QNASL Nasal Aerosol.