Vocabria FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

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

Date	Article
Jan 21, 2021	Approval FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment
Apr 29, 2019	Janssen 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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer