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Yamanouchi Pharmaceutical Co.

U.S. FDA approves new medication

Published in FDA Law Weekly, December 16th, 2004

Vesicare (solifenacin succinate), an anticholinergic agent, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) with symptoms of urgency, frequency, and urge incontinence.

In clinical studies, Vesicare 5 mg and 10 mg (Yamanouchi Pharmaceutical Co., Ltd.) showed clinical and statistical improvements in all symptoms of OAB. Specifically, once-daily Vesicare was found to significantly reduce the number of incontinence episodes for patients during a 12-week study period.

OAB is a medical condition that causes the bladder muscle (known as the detrusor muscle) to contract while the bladder is...

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