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FDA Sides With Lilly; Seeks Class Warning On Antipsychotic Diabetes Risk

Executive Summary

The comparative risk for diabetes among atypical antipsychotics needs further research, FDA says in a letter to six manufacturers requesting a diabetes and hyperglycemia warning across the class

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Geodon “metabolic advantages” user fee date

Pfizer expects an FDA decision on its Geodon (ziprasidone) sNDA claiming "metabolic advantages" that would exempt it from a class warning on diabetes risk by mid-November. Pfizer completed the submission Jan. 22, making Nov. 22 the likely user fee date. All other NDA holders of atypical antipsychotics have complied with FDA's September 2003 request to revise labeling to recommend patient glucose monitoring (1"The Pink Sheet" Sept. 22, 2003, p. 20)...

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