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Janssen Risperdal for bipolar mania

Executive Summary

Janssen's Risperdal (risperidone) approved Dec. 4 for short-term treatment of bipolar mania, as monotherapy or in combination with lithium or valproate. J&J has committed to a long-term bipolar mania study as post-marketing commitment. Updated labeling adds diabetes class warning, removes warnings on QT prolongation. Lilly's Zyprexa (olanzapine) was the first atypical with a short-term bipolar mania indication; Zyprexa is "approvable" for bipolar maintenance (1"The Pink Sheet" Nov. 3, 2003, p. 26)...
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