Aurobindo Pharma Ltd has received final approvals from the US regulator to manufacture and market two hypertension drugs in different dosages.
These are Amlodipine Besylate and Benazepril Hydrochloride capsules of 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg dosages.
The Hyderabad-based company said the US Food and Drug Administration has approved its abbreviated new drug application (ANDA) on the product and it is ready for launch.
Amlodipine Besylate and Benazepril Hydrochloride capsules are the generic bioequivalent to the reference listed drug Lotrel® capsules of Novartis Pharmaceuticals Corp.
The drugs are indicated for the treatment of hypertension in patients not adequately controlled on single drug therapy with either agent and falls under the cardio-vascular (CVS) therapeutic category, a press release from Aurobindo Pharma said.
Annual sales of these two capsules were about $500 million for the 12 months ended March 31, 2012 according to IMS.