Rifapentine · Regulatory approval

FDA approval: Rifapentine

U.S. Food and Drug Administration · June 23, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a regulatory approval notice for rifapentine 150 mg tablet by the FDA, issued 23 June 2026. The record confirms only that the formulation met regulatory requirements for approval; it does not report clinical trial results, efficacy data, or comparative effectiveness.

What was studied

Regulatory approval. Intervention: Rifapentine 150 mg tablet, oral.

Key findings

FDA approval granted for rifapentine 150 mg tablet oral formulation (ANDA217042, approved 2026-06-23)

Safety

This regulatory record does not contain clinical trial results, efficacy data, or safety summaries. No pharmacokinetic, pharmacodynamic, or outcome data are reported.

Who this may help

This approval confirms regulatory clearance for the rifapentine 150 mg tablet; clinicians should refer to approved labeling and prescribing information for indications, dosing, and safety data. This record does not establish clinical benefit or comparative efficacy.

Plain-language summary

FDA approval of a rifapentine tablet formulation; regulatory action does not itself establish clinical efficacy or comparative benefit.

Study design

As stated by the source record.

InterventionRifapentine 150 mg tablet, oral

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-23

Approved formulation strength150 mg

Clinical bottom line

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety summaries.
No information on comparator products, prior approvals, or therapeutic indication is provided.
Underlying NDA or ANDA supporting data are not disclosed in this approval notice.
No pharmacokinetic, pharmacodynamic, or outcome data are reported.

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 reported.

Directness

insufficient

Approval record does not report clinical outcomes or endpoints.

Consistency

insufficient

No comparative data or replication reported in this record.

Risk of bias

insufficient

Regulatory approval does not disclose underlying trial methodology.

Sample adequacy

insufficient

No sample size or trial population described in approval notice.

Source abstract

Drugs@FDA record for application ANDA217042. This is a regulatory action record, not a clinical study. Brand name: RIFAPENTINE. Active ingredient: RIFAPENTINE. Sponsor: MACLEODS PHARMS. Submission type: ORIG (original application). Approval status date: 2026-06-23. Products: RIFAPENTINE, TABLET, ORAL, RIFAPENTINE 150MG.

Follow from this

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

Macleods PharmsRifapentine