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FDA To Review NDA for Oral Antibiotic Faropenem Medoxomil


Posted on 2006-02-23 17:24:00



Replidyne, Inc. and Forest Laboratories, Inc.  announced today that the New Drug Application (NDA) for faropenem medoxomil has been accepted for standard review by the U.S. Food and Drug Administration (FDA).

The NDA for faropenem medoxomil was filed on December 20, 2005 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 of pediatric indications.


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