Shire Fosrenol “approvable”
Executive Summary
Shire will submit additional Fosrenol (lanthanum) data and analysis prior to approval of the non-calcium binder to address issues outlined in FDA "approvable" letter, company says March 3. "Shire is initiating a dialogue with the FDA to agree [to] the balance between pre and post approval commitments which will resolve the questions" The European Union also requested additional data (1"The Pink Sheet" March 3, In Brief)...
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