Johnson & Johnson (JNJ) Pulls File to Extend Velcade's Use in EU
7/5/2012 7:35:03 AM
The European Medicines Agency has been formally notified by US health care giant Johnson & Johnson’s (NYSE: JNJ) European subsidiary Janssen-Cilag International of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorized drug Velcade (bortezomib). On September 2, 2011, Janssen-Cilag submitted an application to extend the marketing authorization for Velcade in combination with rituximab for the treatment of patients with relapsed follicular non-Hodgkin's lymphoma. At the time of the withdrawal the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).