Lupin receives tentative approval for Generic Prezista tablets

30 Dec 2014 Evaluate

Pharma Major 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.

The company’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 U.S sales of $ 1.2 billion.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations as well as biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.

 

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