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Alza Ditropan XL

Executive Summary

Promotional materials for the oxybutynin incontinence drug draws objection from FDA for "omission of material facts" and "overstatement of efficacy." FDA cites a direct-to-consumer letter for statements suggesting greater efficacy for Ditropan XL such as "Help take control...Simply, Confidently"; "Once-a-day confidence"; and"...you may be able to go where you want to go and do what you want - without the constant worry of finding a bathroom"

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