Teva Pharmaceuticals Industries Ltd., (TEVA) Tuesday said the U.S. Food and Drug Administration or FDA has accepted its supplemental new drug application or sNDA for a lower dose QNASL Nasal Aerosol for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age. The sNDA contained data from three double-blind, placebo-controlled studies, which showed that once-daily treatment with QNASL provided significant nasal allergy symptom relief in pediatric subjects with seasonal and perennial allergic rhinitis 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. Further, the company said, if the FDA approves the new indication for QNASL, it will become the first waterless HFA nasal allergy treatment for patients as young as 4 years of age.
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