NDA Accepted for BDP Nasal HFA for Allergic Rhinitis
Teva announced that the FDA has accepted its New Drug Application (NDA) for BDP Nasal HFA (beclomethasone dipropionate hydrofluoroalkane) for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) after its submission in May 2011. The submission is based on a comprehensive clinical development program including results from two Phase 3 clinical trials assessing the safety and efficacy of BDP Nasal HFA in the treatment of SAR and PAR. In both trials, BDP Nasal HFA demonstrated significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion vs. placebo.
BDP Nasal HFA is an inhaled corticosteroid administered as a nonaqueous solution, or “dry spray,” delivered by HFA.
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