Drug-maker Lupin today said it has received approval from the US health regulator to market Amlodipine Benazepril capsules, used for the treatment of high blood pressure, in the American market.
The company's US subsidiary, Lupin Pharmaceuticals, has been granted final approval by the US Food and Drug Administration (USFDA) for Amlodipine Benazepril in strengths of 5mg/40mg and 10mg/40mg capsules, Lupin said in a statement.
Commercial shipment of the product has commenced, it added.
"This approval completes the product line, as the company was granted final approval for Amlodipine Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules in February, 2010," the company said.
The Mumbai-headquartered firm's capsules are the generic equivalent of Novartis' Lotrel capsules, which are indicated for the treatment of hypertension.
In an earlier statement, Lupin Limited Group President and Executive Director Nilesh Gupta had said: "We are very pleased with the approval of our Amlodipine Benazepril capsules. This is a significant approval and it broadens our growing portfolio of cardiovascular medications with a strong complement to our existing product line."
According to IMS Health sales data, Amlodipine Benazepril 5mg/40mg and 10mg/40mg capsules registered annual sales of nearly $290 million for the twelve months ended March, 2011.
As per IMS data, Lupin Pharmaceuticals is ranked second in terms of its share of the overall market for the Amlodipine Benazepril product line.
Shares of Lupin were trading at Rs 450.10 apiece on the Bombay Stock Exchange in late afternoon trade today, up 1.09% from their previous close.
