The FDA has granted marketing approval of Genzyme’s sevelamer carbonate (Renvela) for the control of serum phosphorus in patients with chronic kidney disease drug on dialysis.
Renvela is considered to be an improved version of Renagel (sevelamer HCl), a common phosphate binder.
The FDA has approved revised boxed warnings and safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. ESAs are a bio-engineered version of a protein made in the kidneys that stimulates bone marrow to produce more red blood cells.
A sampling of the new statements addresses the following:
