Basilea Pharma Says FDA Issued Approvable Letter For Ceftobiprole To Treat Skin Structure Infections - Quick Facts

(RTTNews) - Tuesday, Basilea Pharmaceutica Ltd. (BPMUF.PK) announced that the U.S. Food and Drug Administration, or FDA, issued an approvable letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections.

According to the company, the FDA letter showed that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections.

The approval also depends on the assessment of clinical and microbiological data provided, which is not yet reviewed and further characterization of patients with diabetic foot infections.

Further, the company said that the New Drug Application, or NDA, was submitted to the FDA by Basilea's co-development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Ceftobiprole is currently under review by the regulatory authorities in Canada, the European Union and Switzerland, Basilea Pharma noted.

For comments and feedback: contact editorial@rttnews.com Copyright(c) 2008 RealTimeTraders.com, Inc. All Rights Reserved

More News:   Market Updates | Stock Alerts | All Trading News | Stock Index