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Vocabria FDA Approval History

FDA Approved: Yes (First approved January 21, 2021)
Brand name: Vocabria
Generic name: cabotegravir
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection

Vocabria (cabotegravir) is a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with Edurant (rilpivirine) for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as:
  • oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions.
  • oral therapy for patients who will miss planned injection dosing with Cabenuva.

Development Timeline for Vocabria

DateArticle
Jan 21, 2021Approval  FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment
Apr 29, 2019Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV

Further information

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