Treats HIV-1 RNA less than or equal. NDA 219016, held by Janssen Prods. Rilpivirine Hydrochloride.
As of Nov 13, 2026, NDA 219016 (Edurant Ped), held by Janssen Prods, was first approved by FDA on Mar 15, 2024, with 0 approved supplements and 0 published complete response letters.
EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.. Limitations of Use: More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2024 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Edurant PedEQ 2.5MG BASE · tablet, for suspension;oral | Rilpivirine Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
