OrapemTreatment for Bacterial Infection
Replidyne and Forest Laboratories Announce FDA Acceptance for Review of New Drug Application for Oral Antibiotic Faropenem Medoxomil
LOUISVILLE, Colo. and NEW YORK, February 23, 2006 -- Replidyne, Inc. and Forest Laboratories, Inc. (NYSE: FRX) 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.
About Faropenem Medoxomil
Faropenem medoxomil is an ester prodrug derivative of the beta-lactam antibiotic faropenem. The prodrug form of faropenem offers dramatically improved oral bioavailability and leads to higher systemic concentrations of the drug. Faropenem medoxomil is a broad-spectrum antibiotic that is highly resistant to beta-lactamase degradation.
Source: Replidyne, Inc.
Posted: February 2006
- U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem - October 23, 2006
- Replidyne Submits NDA for Orapem - January 9, 2006