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Acute Bacterial Sinusitis
Biopharma company submits NDA for Orapem to treat respiratory tract and skin infections
February 8th, 2006
Replidyne, Inc. announced that the company has submitted a new drug application (NDA) to the U.S. Food & Drug Administration for Orapem (faropenem medoxomil) for the treatment of the following conditions: acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis and uncomplicated skin and skin structure infections. This NDA is the first marketing approval submission for Orapem worldwide and was submitted in the electronic common technical document (eCTD) format. It is also the first NDA submission for the company. The Orapem submission is primarily based on data from eleven phase III clinical trials which...
Source: Immunotherapy Weekly (2006-02-08)
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