Aurobindo Pharma receives final approvals for Felodipine Extended-release tablets

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Felodipine Extended-release tablets USP 2.5mg, 5mg, and 10mg. (ANDA 203417).

Felodipine Extended-release tablets USP 2.5mg, 5mg, and 10mg is the generic equivalent of AstraZeneca’s Plendil Extended-release tablets, 2.5mg, 5mg and 10mg and indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The annual sale of the product is approximately $64 million for the twelve months ending March 2012 according to IMS.

The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 172 ANDA approvals (147 final approvals including 2 from Aurolife Pharma and 25 tentative approvals) from US FDA.

EP News Bureau – Mumbai