Watson announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Irbesartan Tablets, the generic version of Sanofi Aventis‘ 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 (>300mg/day) in patients with type 2 diabetes and hypertension.
Irbesartan Tablets will be available in 75mg, 150mg, and 300mg tablets. Watson intends to begin shipping the product immediately.
For more information call (800) 272-5525 or visit www.watson.com.