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Fosrenol Approval History

FDA Approved: Yes (First approved October 26, 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

DateArticle
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

Further information

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