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Rukobia FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved July 2, 2020)
Brand name: Rukobia
Generic name: fostemsavir
Dosage form: Extended-Release Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection

Rukobia (fostemsavir) is a first-in-class, human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor indicated for use in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.

Development timeline for Rukobia

Jul  2, 2020Approval FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available
Dec  5, 2019ViiV Healthcare submits New Drug Application to the FDA for Fostemsavir, an Investigational, First-in-Class Attachment Inhibitor for the Treatment of HIV in Adults with Few Treatment Options Available
Jul 22, 2019ViiV Healthcare Presents Positive 96-week Data from Phase III Study of Investigational Fostemsavir in Heavily Treatment-Experienced Patients with HIV at IAS 2019

Further information

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