Unichem Laboratories today said it has received American health regulator's tentative approval to market generic version of Sanofi Aventis' Avapro tablets, a hypertension drug, in the US market.
The company has received tentative approval from the United States Food and Drug Administration (USFDA) for Irbesartan tablets in strengths of 75 mg, 150 mg and 300 mg, Unichem Laboratories said in a statement.
Final approval will be received after the patent expires on Dec 7, 2015, it added.
Irbesartan tablets are indicated for the treatment of hypertension and are therapeutically equivalent to Sanofi Aventis' Avapro tablets, it said.
"The product will be commercialised (after the final approval) from Unichem's Ghaziabad plant," the company said.
Shares of Unichem Laboratories today closed at Rs 179.10 on the BSE, up 1.19 per cent from its previous close.
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