Drug firm Aurobindo Pharma today said it has received final approval from the US health regulator to manufacture and market Amlodipine Besylate and Benazepril Hydrochloride capsules, used for treating hypertension, in the American market.
The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Amlodipine Besylate and Benazepril Hydrochloride capsules in the strengths of 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg, Aurobindo Pharma said in a statement.
The capsules are generic bio-equivalent to Novartis Pharmaceuticals Corp's Lotrel capsules and the products are ready for launch, it added.
Quoting IMS health data, the company said annual sales of Amlodipine Besylate and Benazepril Hydrochloride capsules in various strengths stood at nearly $500 million for the twelve months ending March 2012.
The products have been approved out of the company's formulations facility in Hyderabad, it added.
"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," Aurobindo Pharma said.
The company now has a total of 158 Abbreviated New Drug Application (ANDA) approvals with 133 final approvals and 25 tentative approvals from USFDA, it added.
Shares of Aurobindo Pharma were trading at Rs 123.30 in the afternoon trade on the BSE, up 3.35% from its previous close.
