Wockhardt receives final FDA approval for Felodipine ANDA to treat hypertension

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used in treating hypertension. Felodipine is the generic name for the brand Plendil^®, marketed in the United States by Astra Zeneca. Wockhardt is launching the product immediately.

According to IMS Health, the total market for this product in the US was over $66 million. Hypertension and related cardiac diseases remain a major health concern the world over.

"We have received four ANDA approvals in the last 5 days and two of these are extended release pharmaceutical formulations," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "This definitely is a reflection of Wockhardt's R&D prowess in indigenously developing such products," he further added.

In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.

Wockhardt will be manufacturing the Felodipine API in its facility at Ankleshwar, India and the tablets of Felodipine ER at its facility in Aurangabad, India. The technology for the API and the extended-release tables were developed in-house.