Emtricitabine · Regulatory approval

FDA approval: Emtricitabine AND Tenofovir Alafenamide Fumarate

U.S. Food and Drug Administration · April 7, 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 fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide fumarate (equivalent to 25 mg base) on 7 April 2026. This is a regulatory action confirming bioequivalence and manufacturing quality; it does not report clinical trial results or comparative efficacy data.

What was studied

Regulatory approval. Intervention: Emtricitabine and tenofovir alafenamide fumarate fixed-dose combination tablet (emtricitabine 200 mg + tenofovir alafenamide fumarate equivalent to 25 mg base), oral.

Key findings

ANDA214216 approved for emtricitabine and tenofovir alafenamide fumarate tablet formulation on 2026-04-07

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

This approval enables generic substitution and may improve access to a fixed-dose combination antiretroviral. Clinicians should verify that the generic is therapeutically equivalent and appropriate for their patient's treatment regimen; approval does not establish new clinical benefit.

Plain-language summary

FDA approval of a generic fixed-dose combination antiretroviral tablet; confirms bioequivalence and manufacturing standards but does not report clinical trial efficacy data.

Study design

As stated by the source record.

InterventionEmtricitabine and tenofovir alafenamide fumarate fixed-dose combination tablet (emtricitabine 200 mg + tenofovir alafenamide fumarate equivalent to 25 mg base), oral

Reported figures

Quoted from the source exactly as published.

Emtricitabine dose200 mg

Tenofovir alafenamide fumarate dose25 mg base equivalent

Approval date2026-04-07

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No sample size, comparator study, or statistical analysis reported.
Approval assumes bioequivalence to a reference product; the reference product's data are not provided here.
The record does not describe the populations for which this combination is indicated or contraindicated.

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 record; no clinical trial design described.

Directness

insufficient

Approval action; no clinical outcome data reported.

Consistency

insufficient

Single regulatory submission; no comparative efficacy assessment.

Risk of bias

insufficient

Regulatory record does not describe trial conduct or bias assessment.

Sample adequacy

insufficient

No sample size or clinical trial population reported.

Source abstract

Drugs@FDA record for application ANDA214216. This is a regulatory action record, not a clinical study. Brand name: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE. Active ingredient: EMTRICITABINE. Sponsor: MACLEODS PHARMS. Submission type: ORIG (original application). Approval status date: 2026-04-07. Products: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, TABLET, ORAL, EMTRICITABINE 200MG + TENOFOVIR ALAFENAMIDE FUMARATE 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.

EmtricitabineMacleods Pharms