Lupin has received tentative approval for its darunavir ethanolate tablets 75 mg, 150 mg, 300 mg, 400 mg, 600 mg and 800 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Janssen products, LP (Janssen) Prezista tablets 75 mg, 150 mg, 300 mg, 400 mg, 600 mg.
Lupin’s darunavir ethanolate tablets 75 mg, 150 mg, 300 mg, 400 mg, 600 mg are the AB-rated generic equivalents of Janssen’s Prezista tablets and are indicated Lupin’s darunavir tablets is indicated for the treatment of HIV-1 infections.
Prezista tablets had annual US sales of $1.2 billion.
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