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May 13, 2014
08:31 EDTTEVATeva announces FDA acceptance of sNDA filing for pediatric indication of QNASL
Teva Pharmaceuticals Industries announced that the U.S. FDA has accepted for review the company’s supplemental new drug application for a lower dose QNASL Nasal Aerosol for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age. QNASL is a waterless intranasal corticosteroid spray currently available for the treatment of nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years of age and older. The sNDA filing includes data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL in children with allergic rhinitis. The data demonstrated that once-daily treatment with QNASL provided significant nasal allergy symptom relief in pediatric subjects with SAR and PAR when compared with placebo. In all three studies the safety profile of QNASL was similar to that of placebo and adverse events were consistent with those seen in previous clinical studies.
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