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Pharmacia & Upjohn Detrol

Executive Summary

Selectivity claims in a Detrol (tolterodine) brochure suggesting that the drug is selective for overactive bladder versus salivary glands have not been demonstrated in humans, FDA says in an April 13 letter to P&U. The agency also objects to bar graphs in the brochure indicating a 50% decrease in urge incontinence episodes for Detrol patients versus 32% for placebo. The presentation "omits facts material in light of representations concerning the effectiveness of Detrol," FDA says. "Specifically, the difference between the reduction in urge urinary incontinence episodes with Detrol from baseline (-1.2 episodes per 24 hours) and placebo (-0.8 episodes per 24 hours) is not significant"

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