Skip to Content

Prezista Approval History

Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.

Development History and FDA Approval Process for Prezista

Jul 18, 2016Approval U.S. FDA Approves Prezista (darunavir) for Use in Pregnant Women with HIV
Dec 14, 2010Approval FDA Approves Prezista/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Jan 28, 2010Approval U.S. Food and Drug Administration Approves Labeling Update for Prezista To Include 96-Week Data in HIV-1 Infected Adult Patients
Oct 22, 2008Approval U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1
Jun 23, 2006Approval Prezista Tibotec Pharmaceuticals Ltd. - Treatment for Human Immunodeficiency Virus (HIV)
Mar  6, 2006Tibotec Announces FDA Acceptance for Review of NDA for TMC114
Dec 27, 2005New Drug Application for Investigational HIV Protease Inhibitor TMC114 Submitted to U.S. Food & Drug Administration

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.