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Prezista FDA Approval History

FDA Approved: Yes (First approved June 23, 2006)
Brand name: Prezista
Generic name: darunavir
Dosage form: Tablets
Previous Name: TMC114
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

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 timeline 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

Further information

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