Aurobindo Pharma gets US FDA nod for hypertension drug copy

Drug maker Aurobindo Pharma has received final approval from US Food and Drugs Administration to manufacture and market Amlodipine Besylate and Benazepril Hydrochloride capsules in various strengths.

The drug is indicated for treating hypertension in patients and falls under the cardio-vascular therapeutic category.

The capsules are a generic version of Lotrel capsules marketed by Novartis Pharmaceuticals and are ready for launch, the Hyderabad-based company said on Friday.

The annual sales of Amlodipine Besylate and Benazepril Hydrochloride capsules were about USD 500 million in the year ended March 2012, Aurobindo said, citing IMS Health data.

The company now has 158 ANDA (abbreviated new drug application) approvals from US FDA. It includes 133 final approvals and 25 tentative approvals.

Aurobindo Pharma shares were up 3.3% at Rs 123.30 on NSE in noon trade.

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