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Juluca Approval History

FDA Approved: Yes (First approved November 21, 2017)
Brand name: Juluca
Generic name: dolutegravir and rilpivirine
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection

Juluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of virologically suppressed HIV-1 infection.

Development History and FDA Approval Process for Juluca

DateArticle
Nov 21, 2017Approval FDA Approves Juluca (dolutegravir and rilpivirine) for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection
Jun  1, 2017EU and US Submissions for Single Tablet Combining Dolutegravir and Rilpivirine Priority Review Voucher Submitted in US with Anticipated Target Action Date of 6 Months

Further information

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