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Faropenem is an orally-active beta-lactam antibiotic belonging to the penem group. It is the first orally-active penem antibiotic. Faropenem was developed by Daiichi Asubio Pharma, which markets it in two forms.
Additional recommended knowledge
The company also stated their hope to have the product available for commercial sale months before the 2007 influenza season.
Faropenem has yet to receive marketing approval in the United States, and was submitted for consideration by the United States Food and Drug Administration (FDA) on 20 December 2005. The new drug application (NDA) dossier submitted included four proposed indications:
FDA rejects Replidyne’s faropenem Louisville firm drug rejected; considered “nonapprovable’ 10/24/06 The US Food and Drug Administration (FDA) refused to approve faropenem, an antibiotic manufactured by Louisville-based Replidyne. The FDA said the drug was “nonapprovable,” but did not refer to specific safety concerns about the product.
The company will have to conduct new studies and clinical trials, lasting an estimated two more years, to prove the drug treats community-acquired pneumonia, bacterial sinusitis, chronic bronchitis and skin infections.
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Faropenem". A list of authors is available in Wikipedia.|