Watson's Generic Avapro Receives FDA Approval; Will Begin Shipping Immediately

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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.
Posted In: NewsFDA
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