Ortho Biotech reviews ESA Rxing info with FDA

Ortho Biotech Products, a Johnson & Johnson company, is in discussions with the US Food and Drug Administration regarding a safety update to the prescribing information of all erythropoiesis-stimulating agents (ESA), including Procrit (epoetin alfa), based on reports from several investigational studies evaluating ESAs. These data may have an impact on labeling in other parts of the world for Eprex (epoetin alfa), which is marketed by fellow J&J group firm Janssen-Cilag.

Although the exact language of this US label update for ESAs has not been finalized, the company expects new information will appear as a boxed warning and will apply to the oncology and nephrology indications for all marketed ESAs.

In addition, the company has been invited to participate in an upcoming Oncologic Drugs Advisory Committee (ODAC) meeting scheduled for May 10. Ortho Biotech says it supports the FDA's mission to inform healthcare professionals and the public regarding the appropriate uses of prescription therapies, and looks forward to further discussion at the upcoming ODAC event.