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Trogarzo FDA Approval History

Last updated by Judith Stewart, BPharm on July 15, 2024.

FDA Approved: Yes (First approved March 6, 2018)
Brand name: Trogarzo
Generic name: ibalizumab-uiyk
Dosage form: Injection
Company: TaiMed Biologics USA Corp.
Treatment for: HIV Infection

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection.

 

Development timeline for Trogarzo

DateArticle
Dec 13, 2023Approval Theratechnologies Announces FDA Approval of Trogarzo 90-Second Intravenous (IV) Push Loading Dose
Oct  3, 2022Approval Theratechnologies’ Trogarzo Approved by FDA for 30-Second Intravenous (IV) Push, Simplifying HIV Treatment for Heavily Treatment-Experienced Population
Mar  6, 2018Approval FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV

Further information

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