FDA to review Replidyne's, Forest Laboratories' NDA for oral antibiotic

By Lisa Kerner

Erie, Pa., Feb. 23 - Replidyne, Inc. and Forest Laboratories, Inc. said the New Drug Application for faropenem medoxomil has been accepted for standard review by the Food and Drug Administration.

The NDA for faropenem medoxomil was filed on Dec. 20 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 application is based on the results of 11 phase 3 efficacy studies in these indications and a safety database of more than 5,000 patients treated with the product, according to a company news release.

Replidyne and Forest are coordinating additional studies including studies in support of pediatric indications.

Faropenem medoxomil, an ester prodrug derivative of the beta-lactam antibiotic faropenem, is a broad-spectrum antibiotic that is highly resistant to beta-lactamase degradation, the release stated.

Replidyne is a biopharmaceutical company focused on developing and commercializing innovative anti-infective products. The company is located in Louisville, Colo.

New York-based Forest markets a line of products for the treatment of depressive and anxiety disorders, Alzheimer's disease, hypertension, inflammation, alcohol dependence and pain.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.