Teva Allowed to File NDA for Rhinitis Therapy
The approval follows the results from two Phase III trials assessing the safety and efficacy of BDP Nasal HFA in the treatment of SAR and PAR.
The US FDA has allowed drug company Teva to file a New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA) for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
The move follows the results from two Phase III trials assessing the safety and efficacy of BDP Nasal HFA in the treatment of SAR and PAR.
In both trials, BDP Nasal HFA demonstrated improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion versus a placebo.
BDP Nasal HFA, an intranasal corticosteroid, is delivered as a pressurised, non-aqueous aerosol sol
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