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Cardio-Renal panel to address Revatio, phosphate binders

Executive Summary

FDA's Cardiovascular and Renal Drugs Advisory Committee will meet Oct. 16 to discuss extending the use of phosphate binders to the pre-dialysis population. Shire, Genzyme and Fresenius - all of whom have phosphate binders approved for use in controlling serum phosphorus levels in dialysis patients - are scheduled to speak at the first day of the meeting. Genzyme has an NDA pending for Renagel (sevelamer) follow-on Renvela for the pre-dialysis indication. Fresenius markets PhosLo (calcium acetate) and Shire markets Fosrenol (lanthanum) in the United States. The panel will also discuss data requirements and study designs for a pediatric indication for Pfizer's Revatio (sildenafil) in pulmonary arterial hypertension Oct. 17...
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PS048684

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