Hyderabad-based drug firm Aurobindo Pharma Limited has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Felodipine Extended-release tablets. The Felodipine extended-release tablets in 2.5mg, 5mg, and 10mg are the generic equivalent of AstraZeneca’s Plendil extended-release tablets of 2.5mg, 5mg and 10mg, and used for the treatment of hypertension and lower blood pressure, according to a company release. The annual sale of the product is approximately $64 million for the twelve months ending March 2012 according to IMS, the release said.
The product has been approved out of Unit VII special economic zone formulations facility in Hyderabad. With this, Aurobindo Pharma now has a total of 172 abbreviated new drug application (ANDA) approvals (147 final approvals including 2 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA. The company's scrip is currently trading at Rs 192 on the Bombay Stock Exchange, up 1.83% over the previous close of Rs 188.55.