Johnson & Johnson subsidiary Centocor Ortho Biotech received FDA approval for Simponi, an injectable treatment for arthritis caused by immune-system disorders. According to an AP report, the drug is a potential blockbuster, and a follow-up to Remicade, a multibillion-dollar seller. Simponi will be marketing in the US by J&J, and in Europe by Schering-Plough.
FDA authorized a relaxed indication and distribution of Roche‘s and GlaxoSmithKline‘s antiviral drugs – Tamiflu and Relenza, respectively – in order to combat swine flu. Public health officials and volunteers will be allowed to distribute the meds, and both drugs will be available off-label, based on FDA’s “Emergency Use Authorization” provision.
