Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing extended-release tablets containing 2.5 mg, 5 mg and 10 mg felodipine, which are used in treating hypertension. As per the company release, felodipine is the generic name for the brand Plendil, marketed in the US by Astra Zeneca. Wockhardt will soon launch the product.
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.
Dr Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt, “We have received four ANDA approvals in the last five days and two of these are extended release pharmaceutical formulations. This definitely is a reflection of Wockhardt’s R&D prowess in indigenously developing such products.”
Wockhardt will manufacture the Felodipine API in its facility at Ankleshwar and the tablets of Felodipine ER at its facility in Aurangabad. The technology for the API and the extended-release tables were developed in-house.
EP News Bureau