AMGEN and Ortho Biotech have finalized the United States Food and Drug Administration (FDA) approved changes in the labeling information for the ESA class of drugs including Aranesp (darbepoetin alfa), EPOGEN (Epoetin alfa), and Procrit (Epoetin alfa). These changes include modifications to the BOXED WARNINGS, USAGE, and DOSAGE AND ADMINISTRATIONS sections for cancer patients on chemotherapy.
AMGEN and Ortho Biotech are informing healthcare professionals about the revisions to the U. S. prescribing information through a joint Dear Healthcare Professional letter. In addition to communicating the changes in the labeling, the letter also includes information about the new FDA Medication Guide and Patient Instruction requirements for the ESA class of drugs. The letter, updated prescribing information, Medication Guide, and Patient Instructions are posted on www.aranesp.com and www.procrit.com.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment