Faropenem is an orally active beta-lactam antibiotic belonging to the

penem A penem is a type of β-lactam with an unsaturated five-member heterocycle containing a sulfur atom in a pentacyclic ring fused to the β-lactam ring. Penems do not occur naturally; all are synthetic. Related to penems are carbapenems, which hav ...

group. It is resistant to some forms of extended-spectrum

beta-lactamase Beta-lactamases (β-lactamases) are enzymes () produced by bacteria that provide multi-resistance to beta-lactam antibiotics such as penicillins, cephalosporins, cephamycins, monobactams and carbapenems ( ertapenem), although carbapene ...

. It is available for oral use.

Forms

Faropenem was developed by Daiichi Asubio Pharma, which markets it in two forms. * The sodium salt faropenem sodium, available under the trade name Farom, has been marketed in Japan since 1997. () * The sodium salt faropenem sodium, available under the trade name Orfanem, has been marketed in Bangladesh by Incepta Pharmaceuticals Ltd. * The prodrug form faropenem medoxomil (also known as faropenem daloxate) has been licensed from Daiichi Asubio Pharma by Replidyne, which plans to market it in conjunction with Forest Pharmaceuticals. The trade name proposed for the product was Orapem, but company officials recently announced this name was rejected by the FDA.(Q1 06 Investor Conf Call)()

Clinical use

As of 8 September 2015, Faropenem has yet to receive marketing approval in the United States, and was submitted for consideration by the United States

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) on 20 December 2005. The new drug application dossier submitted included these proposed indications: * acute bacterial sinusitis * community-acquired pneumonia * acute exacerbations of chronic bronchitis * uncomplicated skin and skin structure infections * urinary tract infections

History

The 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. In India it is available under the name Farokaa, and in Bangladesh as Orfanem.

References

External links

DrugBank website
{{CephalosporinAntiBiotics Carbapenem antibiotics Tetrahydrofurans