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Bacteria
Replidyne and Forest Laboratories announce FDA review of NDA for faropenem medoxomil
March 24th, 2006
Replidyne, Inc. and Forest Laboratories, Inc. (FRX) announced that the new drug application (NDA) for faropenem medoxomil has been accepted for standard review by the U.S. Food & Drug Administration (FDA). The NDA for faropenem medoxomil was filed for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections in adults. The NDA is based on the results of 11 phase III efficacy studies in these indications and a safety database of more than 5,000 patients treated with the product. Replidyne and Forest are coordinating additional studies including studies in support...
Source: Drug Week (2006-03-24)
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