Wockhardt secures USFDA approval for anti-hypertension drug
The pharma company will market Felodipine tablets in the strength of 2.5 mg, 5 mg and 10 mg in the US.
New Delhi, August 21, 2012: The Indian pharma major, Wockhardt today said that the company has received the final approval from United States Food and Drug Administration (USFDA), the US health regulator to market generic Felodipine tablets in the US. It may be noted here that Felodipine is the generic name for the Astra Zeneca's Plendil tablets and will be used to treat hypertension in the US.
The company said in a statement that it has received the approval for marketing Felodipine extended release tablets in the strengths of 2.5 mg, 5 mg and 10 mg. The company is planning to launch the product immediately in the market.
"We have received four ANDA approvals in the last five days and two of these are extended release pharmaceutical formulations," said Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt.
The market for this product in the US is worth over US$ 66 million, according to IMS Health Data.
Wockhardt will manufacture the Felodipine API tablets in its Ankleshwar facility and extended release tablets at its Aurangabad unit in Maharashtra.