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Overactive bladder patients can now find relieve in Toviaz,
a drug made by Germany’s
Schwarz Pharma and distributed in the US
by Pfizer Inc of New York,
which gained the Food and Drug Administration approval on Friday.
The drug relaxes the smooth tissue of the bladder reducing
this way the urinary frequency, urge to urinate, and sudden urinary
incontinence, the most significant symptoms of overactive bladder.
The Food and Drug Administration gave its approval based on
two 12-week studies involving 554 patients who were given the 4-milligram dose,
the 8-milligram dose or a placebo. Patients given the 4-milligram dose knew the
best results in reducing urinary frequency.
George Benson, deputy director, Division of Reproductive and
Urologic Products at the FDA's Center for Drug Evaluation and Research said the
new drug “will provide an additional treatment option to help them manage
problems with an overactive bladder.
However, patient given the drug may also experience dry
mouth, constipation and dry eyes. Therefore, patients already facing these conditions
must not be prescribed the drug, the Food and Drug Administration required.
Also, patient suffering from severe reduced kidney function should avoid taking
the drug.
Anyone experiencing any side effects or product quality
problems with Toviaz should report them to the FDA’s MedWatch Adverse Event
Reporting program.
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