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Lilly Cymbalta manufacturing remains delayed

Executive Summary

Lilly receives second "approvable" letter for Cymbalta (duloxetine) Sept. 29 citing manufacturing issues still to be resolved. Lilly expects FDA's overall assessment of GMP compliance in its Indianapolis plants by year-end. Cymbalta approval is also contingent on labeling negotiations. No more trials will be necessary for Cymbalta, which had been a concern following an "approvable" letter for duloxetine's stress urinary incontinence indication requesting additional studies (1"The Pink Sheet" Sept. 8, 2003, p. 4)...
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