Aurobindo Pharma receives US FDA approval for amlodipine besylate and benazepril hydrochloride capsules

Products have been approved out of Aurobindo Pharma’s Unit VII (SEZ) formulations facility in Hyderabad

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg (ANDA 202239). The products are ready for launch.

Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg are the generic bioequivalent to the reference listed drug Lotrel Capsules of Novartis Pharmaceuticals Corp. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent and falls under the cardio-vascular (CVS) therapeutic category.

The annual sales of Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg is approximately $500 million for the twelve months ending March 2012 according to IMS.

The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 158 ANDA approvals (133 Final approvals including 1 from Aurolife.Pharma and 25 tentative approvals) from US FDA.

EP News Bureau