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Renvela Approval History

  • FDA approved: Yes (First approved October 19th, 2007)
  • Brand name: Renvela
  • Generic name: sevelamer carbonate
  • Dosage form: Tablets
  • Company: Genzyme Corporation
  • Treatment for: Hyperphosphatemia of Renal Failure

Renvela (sevelamer carbonate) is a calcium-free, metal-free, non-absorbed phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

Development History and FDA Approval Process for Renvela

Oct 22, 2007Approval FDA Approves Genzyme's Renvela for Dialysis Patients
Dec 21, 2006Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis

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