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VESIcare FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved November 19, 2004)
Brand name: VESIcare
Generic name: solifenacin succinate
Dosage form: Tablets
Company: Astellas Pharma US, Inc.
Treatment for: Overactive Bladder

VESIcare (solifenacin) is a muscarinic receptor antagonist for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
VESIcare LS is an oral suspension formulation of solifenacin for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.

Development timeline for VESIcare

May 27, 2020Approval FDA Approves VESIcare LS (solifenacin succinate) Oral Suspension for Neurogenic Detrusor Overactivity (NDO) Pediatric Patients
Nov 19, 2004Approval FDA Approves Vesicare (solifenacin succinate) for the Treatment of Overactive Bladder

Further information

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