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www.fdanews.com/articles/67119-novartis-receives-us-approval-for-overactive-bladder-treatment

NOVARTIS RECEIVES US APPROVAL FOR OVERACTIVE BLADDER TREATMENT

January 4, 2005

According to reports, Switzerland-based pharmaceuticals producer Novartis has received US FDA approval for Enablex extended-release tablets (7.5 mg and 15 mg), for the treatment of overactive bladder (OAB) with symptoms including urge incontinence. Novartis expects to launch the drug, which blocks the brain's M3 receptor controlling bladder muscle movements, in early 2005. The medicine's annual sales are expected to total up to US$1bn, with OAB sufferers in the US estimated to total 17mn.

According to company sources, the compound darifenacin was originally acquired from US drug major Pfizer in March 2003 for some US$225mn, pending US FDA and European Commission approval. A new drug application was filed in 2002.