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