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Cabenuva Approval Status

FDA Approved: No
Brand name: Cabenuva
Generic name: cabotegravir and rilpivirine
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

Cabenuva (rilpivirine and cabotegravir) is a once-monthly, injectable, two-drug regimen of long-acting rilpivirine (approved in tablet form as Edurant) and the investigational integrase inhibitor cabotegravir, in development for the treatment of HIV in adults.

Development Status and FDA Approval Process for Cabenuva

DateArticle
Aug 22, 2019Janssen Reports Positive Top-line Phase 3 Study Results of Investigational, Long-acting Injectable HIV Treatment Regimen Administered Every Two Months
Jul  8, 2019ViiV Healthcare Announces Start of First-Ever Study to Identify and Evaluate Approaches to Implementing its Once-Monthly Injectable HIV Treatment in Clinical Practice
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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