FDA recently approved availability of an 800 mg tablet strength for Prezista (darunavir), an HIV-1 protease inhibitor (PI) indicated for the treatment of HIV-1 infection.  The Dosage and Administration section has been changed, in part, to read: Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions: 800 mg (one 800 mg tablet or two 400 mg tablets) taken with ritonavir 100 mg once daily and with food.

Prezista is a product of Janssen Pharmaceuticals, Inc.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration