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Watson Pharmaceuticals
WPI today announced that its subsidiary Watson Laboratories, Inc. has
received approval from the U.S. Food and Drug Administration (FDA) on its
Abbreviated New Drug Application (ANDA) for Irbesartan Tablets USP, 75 mg, 150
mg and 300 mg, the generic equivalent to Sanofi's Avapro^®. Watson intends to
begin shipping the product immediately.
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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