FDA Accepts NDA for Allergic Rhinitis Treatment
The FDA has accepted for filing Teva's New Drug Application for a nasal aerosol corticosteroid in development for the treatment of allergic rhinitis.
Teva Pharmaceutical Industries announced Monday that the U.S. FDA has accepted for filing Teva's New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA), a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
The submission is based on a comprehensive clinical development program including results from two Phase III 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 versus placebo. BDP Nasal HFA was generally well tolerated and the safety profile was similar to that of placebo.
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