Unichem Laboratories Limited has received the ANDA approval from the US FDA for Irbesartan and Hydrochlorothiazide tablets USP, 150 mg/12.5 mg, and 300 mg/12.5 mg, which are therapeutically equivalent to Avalide tablets 150 mg/12.5 mg, and 300 mg/12.5 mg of Sanofi-Aventis US LLC.
Irbesartan and Hydrochlorothiazide is a combination of Irbesartan, an angiotensin II receptor antagonist and Hydrochlorothiazide, a thiazide diuretic. This product is indicated for hypertension in patients not adequately controlled with monotherapy and also as an initial therapy with hypertension likely to need multiple drugs to achieve their blood pressure goals.
The product will be commercialized from Unichem's Ghaziabad plant. Active pharmaceutical ingredient (API) will also be made in house at Pithampur/Roha API plant(s).