Rilpivirine · Regulatory approval

FDA approval: Rilpivirine

U.S. Food and Drug Administration · July 10, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a generic formulation of rilpivirine hydrochloride (25 mg tablet) via ANDA review on 2026-07-10, manufactured by Laurus. This is a regulatory action confirming bioequivalence and manufacturing quality, not a clinical efficacy or safety study.

What was studied

Regulatory approval. Intervention: RILPIVIRINE HYDROCHLORIDE, tablet, oral, 25 mg base.

Key findings

FDA approved RILPIVIRINE HYDROCHLORIDE tablet, 25 mg base strength, on 2026-07-10

Safety

This record does not report clinical trial outcomes, efficacy data, or safety studies. No comparative efficacy, adverse event rates, or patient population data are provided.

Who this may help

Approval confirms the generic rilpivirine formulation is bioequivalent to the reference product and meets FDA manufacturing and quality standards. Clinicians may prescribe this formulation interchangeably with the brand product; no new efficacy or safety data are provided by this approval.

Plain-language summary

FDA approval of a generic rilpivirine tablet formulation; regulatory action confirming bioequivalence and manufacturing standards, not a clinical efficacy trial.

Study design

As stated by the source record.

InterventionRILPIVIRINE HYDROCHLORIDE, tablet, oral, 25 mg base

Reported figures

Quoted from the source exactly as published.

Drug strength25 mg base

Approval date2026-07-10

Clinical bottom line

Caveats

This record does not report clinical trial outcomes, efficacy data, or safety studies.
Bioequivalence study details, comparator product name, and trial results are not disclosed in this regulatory summary.
No comparative efficacy, adverse event rates, or patient population data are provided.
Approval refers to manufacturing and bioavailability parity with reference product, not clinical superiority.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory approval record; no clinical study design reported.

Directness

insufficient

Record does not report clinical outcomes or efficacy data.

Consistency

insufficient

Single approval action; no comparative data provided.

Risk of bias

insufficient

Regulatory record; trial methodology and bias assessment not reported.

Sample adequacy

insufficient

No clinical sample size or trial population disclosed.

Source abstract

Drugs@FDA record for application ANDA219788. This is a regulatory action record, not a clinical study. Brand name: RILPIVIRINE. Active ingredient: RILPIVIRINE. Sponsor: LAURUS. Submission type: ORIG (original application). Approval status date: 2026-07-10. Products: RILPIVIRINE HYDROCHLORIDE, TABLET, ORAL, RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

LaurusRilpivirine