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FDA NDA · NDA212888

CABENUVA

cabotegravir and rilpivirine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA212888
TYPE
NDA
ORIGINAL APPROVAL
2021-01-21
LATEST ACTION
2025-11-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CABENUVA KIT · ReferencePrescription
CABOTEGRAVIR 400MG/2ML (200MG/ML), RILPIVIRINE 600MG/2ML (300MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
CABENUVA KIT · ReferencePrescription
CABOTEGRAVIR 600MG/3ML (200MG/ML), RILPIVIRINE 900MG/3ML (300MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-11-26Labeling · Supplement 17 · standard — Label ↗AP
2025-04-11Labeling · Supplement 16 · standard — Letter ↗AP
2024-09-20Efficacy · Supplement 15 · priority — Letter ↗AP
2023-12-13Labeling · Supplement 11 · standard — Letter ↗AP
2023-02-27Labeling · Supplement 8 · standard — Label ↗AP
2022-03-29Efficacy · Supplement 6 · priority — Letter ↗AP
2022-03-29Efficacy · Supplement 5 · priority — Letter ↗AP
2022-03-23Efficacy · Supplement 3 · standard — Letter ↗AP
2022-02-07Efficacy · Supplement 2 · standard — Letter ↗AP
2022-01-31Efficacy · Supplement 1 · standard — Letter ↗AP
2021-01-21Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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