Janssen-Cilag has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has decided to delay the European Commission decision process on Zevtera (ceftobiprole medocaril) pending completion of a Good Clinical Practice (GCP) inspection.
The drug is in the final stage of approval for the treatment of complicated skin and soft tissue infections. This application for approval was based on the results of two Phase III trials which demonstrated that Zevtera was not inferior to comparator regimens as a treatment for complicated skin and soft tissue infections.
The regulatory review process is ongoing in the US and Australia, among other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections.
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