Genzyme announced an FDA marketing approval for Mozobil (plerixafor injection), a drug to be used in combination with a granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma. The product also received an orphan drug designation.
Following an FDA safety alert on oral sodium phosphates (OSP), C.B. Fleet has announced a voluntary recall of over-the-counter products Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. The FDA recommended that these products not be used for bowel cleansing. Two prescription OSPs manufactured by Salix Pharmaceuticals, Visicol and OsmoPrep, were given box warnings related to the risk of acute kidney injury.