Wockhardt receives US FDA approval for cardiac drug

Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.

Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing the cardiac drug.

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Wockhardt will be marketing 25 mg, 50 mg, 100 mg and 200 mg extended-release tablets of metoprolol succinate, which is used for 24-hour control of hypertension, treatment of angina and in improvement of survival after heart attack.

Metoprolol succinate is the generic name for the brand Toprol XL, marketed in the United States by Astra Zeneca. The product is being launched immediately, a company statement said in Mumbai.

"Metoprolol succinate extended release tablets is one of the most challenging oral pharmaceutical products to develop and stabilize, a fact demonstrated by the fact that Wockhardt will be only the second generic version of Toprol XL in the market today" Wockhardt's Chairman, Habil Khorakiwala said.

"Wockhardt's ANDA program focuses on high-value, hi-tech products such as complex extended release products. We have also created very specialized and large manufacturing capacity to manufacture this product, which will ensure uninterrupted supply," Khorakiwala said.