Aurobindo Pharma, a Rs.4,550 crore pharma major from Hyderabad, has received final approval from the US FDA to manufacture and market felodipine extended-release tablets USP 2.5mg, 5mg, and 10mg. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad and it now has a total 172 ANDA approvals from US FDA.
Felodipine extended-release tablets are the generic equivalent of AstraZeneca's Plendil extended-release tablets and indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, strokes and myocardial infarctions. The annual sale of the product is approximately US$ 64 million for the twelve months ending March 2012 according to IMS.