Saturday, November 1, 2008

FDA approves new drug to treat overactive bladder

WASHINGTON, Oct. 31 -- The U.S. Food and Drug Administration has approved a new drug, Toviaz (fesoterodine fumarate), to help patients suffering from overactive bladder (OAB), according to a statement by the agency on Friday.

The drug works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence, that are characteristic symptoms of OAB.

"Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest," said George Benson, deputy director, Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research. "This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."

Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc. of New York, N.Y.. The drug will be available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be administered once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults.


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