Wockhardt on Tuesday said it has received final approval from the US health regulator to market generic Felodipine tablets used for treating hypertension in the United States.
The company has received final approval from the United States Food and Drug Administration (USFDA) for marketing Felodipine extended release tablets in the strengths of 2.5 mg, 5 mg and 10 mg, Wockhardt said in a statement.
Felodipine is the generic name for the Astra Zeneca’s Plendil tablets.
“We have received four ANDA approvals in the last five days and two of these are extended release pharmaceutical formulations,” Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
According to IMS Health data, the total market for this product in the US was over $66 million.
The company will be manufacturing the Felodipine API in its Ankleshwar facility and extended release tablets at the firm’s Aurangabad unit in Maharashtra, it added.
Shares of Wockhardt Ltd today closed at Rs 1,263.40 per share on BSE, down 2.71 per cent from its previous close.