USFDA approves Aurobindo Pharma's hypertension drugs
07 Sep 2012
The US Food & Drug Administration (USFDA) has given final approvals to Aurobindo Pharma Ltd to manufacture and market two hypertension drugs, Amlodipine Besylate and Benazepril Hydrochloride capsules of 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg dosages in the United States.
Hyderabad-based Aurobindo Pharma said the US Food and Drug Administration had approved its abbreviated new drug application (ANDA) on the product and it was ready for launch.
The drugs - Amlodipine Besylate and Benazepril Hydrochloride capsules - are the generic bioequivalent to the reference listed drug Lotrel capsules of Novartis Pharmaceuticals Corp and are indicated in the treatment of hypertension in patients not adequately controlled on single drug therapy with either agent, the company said.
Annual sales of the two capsules were about $500 million for the 12 months ended 31 March 2012, according to IMS data.
These latest approvals take the company's number of drugs with ANDA approval to 158, of which 133 are final approvals, including one from Aurolife Pharma LLC, wile 25 are tentative approvals.
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