Sun Pharmaceutical Industries today said it had received tentative approval from the US health regulator for its generic clopidogrel tablets used for treating heart ailments.
United States Food and Drug Administration (USFDA) has granted the company's subsidiary a tentative approval for its abbreviated new drug application (ANDA) for generic clopidogrel tablets USP, Sun Pharmaceutical said in a statement.
The generic clopidogrel tablets USP in the strength of 75 mg are equivalents of Sanofi Aventis's Plavix tablets.
"Clopidogrel tablets USP have annual sale of about $6 billion in America," Sun Pharmaceuticals said.
"The tablets are indicated for the treatment of acute coronary syndrome, recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease," it added.
Shares of Sun Pharmaceutical Industries today closed at Rs 516.80 on the Bombay Stock Exchange (BSE), down 0.31% from its previous close.