Basilea Announces Submission of Marketing Authorization Application for Ceftobiprole by Janssen-Cilag AG to Swiss Regulatory Authority
Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today the submission of a marketing authorization application for ceftobiprole to Swissmedic by its license partner Janssen-Cilag AG, a Johnson & Johnson company. This submission is for the use of ceftobiprole in the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections.
Swissmedic had previously granted accelerated assessment of the marketing authorization application (“Beschleunigtes Zulassungsverfahren”) for ceftobiprole for the treatment of complicated skin and soft tissue infections.
Ceftobiprole is currently under review by regulatory authorities in the U.S., Canada and in the European Union.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International.
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