Unichem Laboratories receives final ANDA approval from USFDA for Irbesartan Tablets USP

08 Dec 2015 Evaluate

Unichem Laboratories has received final ANDA approval (tentative approval was received earlier) from the United States Food and Drug Administration (USFDA) for Irbesartan Tablets USP. Irbesartan Tablets USP 75mg, 150mg and 300mg are therapeutically equivalent to Avapro Tablets, 75mg, 150mg and 300 mg of Sanofi-aventis U.S.LLC.

Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Irbesartan 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. In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation). The product will be commercialized from the company’s Ghaziabad plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur API Plant.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.

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