New-strength Prezista cleared by FDA

TITUSVILLE, NJ – Janssen Therapeutics announced the US Food and Drug Administration approval of its new 800mg tablet of PREZISTA (darunavir) for once daily oral administration. Prezista is used for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients without mutations associated with darunavir resistance.

Prezista is always taken with and at the same time as ritonavir with food and in combination with other HIV drugs. The new tablet strength will allow the reduction of the number of tablets by half, taking one 800 mg tablet instead of two 400 mg tablets once a day with ritonavir 100 mg and other antiretroviral medications.

The 800 mg tablet is expected to be available shortly, while Janssen plans to discontinue the 400 mg tablet. The company will also provide educational materials about the new tablet to pharmacies to help the transition.