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news.Israeli generic drug developer Teva Pharmaceutical has received the US Food and Drug Administration (FDA) acceptance to submit new drug application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA) to treat perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR).
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The NDA is supported by the results of two Phase III clinical trials evaluating the efficacy and safety of BDP Nasal HFA which showed improvement in nasal symptoms such as runny nose, nasal itching sneezing and nasal congestion versus placebo.
The trials’ results suggested that the drug was generally well tolerated and showed safety profile.
Teva Group Global Branded Products vice president Yitzhak Peterburg said BDP Nasal HFA has demonstrated promising results in the treatment of both SAR and PAR.