FDA Approves VESIcare LS (solifenacin succinate) for Neuroge
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The U.S. Food and Drug Administration granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older.

• This is the first FDA-approved treatment for NDO patients as young as two years of age.

• Prior to this approval, the current standard of care for many of these patients required up to three times a day dosing, and this treatment requires only once a day dosing.

• The most common side effects of VESIcare LS are constipation, dry mouth, and urinary tract infection.

• Severe allergic reactions, such as angioedema (swelling beneath the skin) and anaphylaxis, have been reported in patients treated with solifenacin succinate and may be life-threatening.

• The approval of VESIcare LS was granted to Astellas Pharma US, Inc.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-form-bladder-dysfunction-pediatric-patients-young-2-years-age
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