The company has received tentative approval from the United States Food and Drugs Administration (FDA) to market its Darunavir Ethanolate tablets in multiple strengths in the American market, Lupin said in a statement.
Darunavir tablets are indicated for the treatment of HIV-1 infections. According to IMS MAT September, 2014 sales data, Janssen's Prezista tablets had annual US sales of USD 1.2 billion.
Last week, the Mumbai-based company had received US health regulator's approval to market a generic version of ViiV Healthcare's Epivir Tablets, used in treating HIV infection, in the American market.
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