Cardio-Renal panel to address Revatio, phosphate binders
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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