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Shire Fosrenol "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire's non-calcium phosphate binding agent Fosrenol (lanthanum carbonate) is "approvable" Feb. 28 for treatment of end-stage renal disease patients undergoing hemodialysis. FDA is asking for additional data and analysis to address "a number of remaining questions," firm says. The agency previously requested a study examining long-term efficacy in bone histology (Pharmaceutical Approvals Monthly, Feb. 1, p. 3). Shire continues to forecast a U.S. launch prior to the end of 200

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