Wockhardt gets final USFDA approval for anti-hypertension drug
New Delhi: Drug firm Wockhardt 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.
The company said it will launch the product immediately.
"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 USD 66 million, the Mumbai-based firm said.
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 on Tuesday closed at Rs 1,263.40 per scrip on BSE, down 2.71 percent from its previous close.