Mumbai: Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing tablets of Clopidogrel bisulfate and a tentative approval for the tablets Clopidogrel bisulfate, which are used to help reduce risk of heart attack or stroke.
Clopidogrel is the generic name for brand Plavix, marketed in the United States by Bristol-Myers Squibb. Wockhardt is launching the product immediately, a company statement said here.
According to IMS Health, the total market for this product in the US was over USD 6,500 million. Prevalence of atherosclerotic diseases is rapidly growing the world over. But by inhibiting the clotting within blood vessels, it reduces risk of heart attacks and strokes and is one of the most used pharmaceutical products in the world.
"We have received two ANDA approvals in the last three days," Wockhardt chairman Habil Khorakiwala said.
"Wockhardt`s rapidly growing presence has been aided in large, by the steady stream of new products," he said.
Wockhardt will be manufacturing the Clopidogrel bisulfate API in its facility at Ankleshwar, India and the tablets of Clopidogrel at its facility in Aurangabad, India. The technology for the API and the tables were developed in-house, it said.
PTI
