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FDA approves Watson Laboratories’ generic Sanctura ANDA

Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) of Trospium Chloride Extended-release Capsules.

Watson anticipates beginning the shipment of the product immediately.

The generic equivalent to Allergan’s Sanctura XR is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Sanctura XR had total US sales of approximately $67m, for the 12 months ending 31 July 2012, according to IMS Health data.

Watson Pharmaceuticals is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women’s health.