Lupin receives USFDA approval for HIV drug
The US drug regulator has given its nod for Lupin's darunavir ethanolate tablets, which are the generic versions of Janssen's Prezista tablets
The US Food and Drugs Administration (USFDA) has granted tentative approval to Lupin Limited for marketing its darunavir ethanolate tablets 75 mg, 150 mg, 300 mg, 400 mg, 600 mg and 800 mg in the US.
Lupin's darunavir ethanolate tablets are the AB-rated generic equivalents of Janssen’s Prezista tablets and are indicated for the treatment of HIV-1 infections.
As per IMS MAT September 2014, Prezista tablets had annual US sales of $ 1.2 billion.
Lupin's darunavir ethanolate tablets are the AB-rated generic equivalents of Janssen’s Prezista tablets and are indicated for the treatment of HIV-1 infections.
As per IMS MAT September 2014, Prezista tablets had annual US sales of $ 1.2 billion.