Watson Pharmaceuticals Inc. (WPI) announced that its subsidiary Watson Laboratories, Inc. - Florida has received approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application or ANDA for Trospium Chloride Extended-release Capsules, the generic equivalent to Allergan's (AGN) Sanctura XR.
Watson said it intends to begin shipping the product immediately.
Sanctura XR is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
For the 12 months ending July 31, 2012, Sanctura XR had total U.S. sales of approximately $67 million according to IMS Health data.
In a separate press release, Watson Pharmaceuticals announced that its subsidiary Watson Laboratories, Inc. has received approval from the FDA on its ANDA for Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, the generic equivalent to Sanofi's (SNY) Avapro.
Avapro is indicated for the treatment of hypertension when used alone or in combination with other antihypertensive agents. It is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension.
For the 12 months ending August 31, 2012, Avapro and its generic equivalents had total U.S. sales of approximately $390 million according to IMS Health data.
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