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Fosrenol Approval History

  • FDA approved: Yes (First approved October 26th, 2004)
  • Brand name: Fosrenol
  • Generic name: lanthanum carbonate
  • Dosage form: Chewable Tablets
  • Company: Shire Pharmaceuticals Group plc
  • Treatment for: Hyperphosphatemia of Renal Failure

Fosrenol is a phosphate binder used to reduce high phosphorus levels in end-stage renal disease (ESRD) patients.

Development History and FDA Approval Process for Fosrenol

Oct 26, 2004Approval Fosrenol Shire Pharmaceuticals Group plc - Treatment for Hyperphosphataemia in ESRD Patients
Jul 20, 2004Fosrenol: FDA Action Date Extended, US Launch Target Unaffected

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