New Delhi: Unichem Laboratories has received final approval from the US health regulator to market generic Irbesartan tablets, used in treating hypertension, in the American market.
The company has received final abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Irbesartan tablets, Unichem Laboratories said in a filing to the BSE.
The tablets are therapeutically equivalent to Sanofi- -aventis's Avapro tablets, which are indicated for the treatment of hypertension. It is also used for the treatment of diabetic nephropathy.
"The product would be commercialised from Unichem's Ghaziabad plant. Active Pharmaceutical Ingredient (API) for the product would also made in-house at Pithampur plant," the company said.
