Aurobindo gets USFDA approval for hypertension drug

NEW DELHI: Aurobindo Pharma today said it has received US health regulator's approval to market generic version of blood pressure lowering medicine Plendil Extended-release tablets in the American market.

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Felodipine Extended-release Tablets USP in strengths of 2.5 mg, 5 mg, and 10 mg, Aurobindo Pharma said in a statement.

Felodipine Extended-release tablets are the generic equivalent of AstraZeneca's Plendil Extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure, it added.

"The annual sale of the product is nearly $ 64 million for the twelve months ending March 2012 according to IMS," the company said.

It added that the product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.

Aurobindo now has a total of 172 abbreviated new drug applications (ANDA) approvals from the USFDA, the company said.

Shares of Aurobindo were trading at Rs 192 on the BSE in late afternoon trade, up 1.83 per cent from its previous close.