Drug firm Wockhardt said it has received American health regulator’s approval to market clopidogrel bisulfate tablets used for reducing risk of heart attack, in the US market.
The company has received final approval from the US Food and Drug Administration (USFDA) to market clopidogrel bisulfate tablets in strength of 300 mg, Wockhardt said in a filing to the BSE.
The Mumbai-based firm has also received a tentative approval from USFDA for 300 mg clopidogrel bisulfate tablets. Wockhardt said it is launching the product immediately in the US market.
“We have received two abbreviated new drug application (ANDA) approvals in past three days and we are expecting a few more shortly,” Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
“Wockhardt’s rapidly growing presence has been aided in large by the steady stream of new products,” Khorakiwala added. Wockhardt’s product is the generic version of Bristol-Myers Squibb’s Plavix tablets.
According to IMS health sales data, total market for clopidogrel bisulfate tablets in the US market is estimated to be around $6.5 billion. “Wockhardt will be manufacturing the clopidogrel tablets at its facility in Aurangabad,” it said.
Shares of Wockhardt touched a new high of Rs 1,274.95 on the BSE in afternoon trade, up 3 percent from its previous close.