Isotretinoin · Regulatory label update

FDA supplemental approval: Claravis (Labeling)

U.S. Food and Drug Administration · August 21, 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 U.S. FDA supplemental approval record documenting a labeling change for Claravis (isotretinoin 10 mg capsules) issued on 21 August 2026. The record confirms regulatory action but does not report clinical trial results, efficacy data, or safety findings; it is a regulatory housekeeping document only.

What was studied

Regulatory label update. United States.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety analyses. This is a regulatory administrative action only; it does not constitute evidence of clinical benefit or harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of labeling for an established isotretinoin product; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

Study design

As stated by the source record.

SettingUnited States

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-21

Product strengthISOTRETINOIN 10MG

Caveats

This record does not contain clinical trial results, efficacy data, or safety analyses.
The specific labeling changes are not detailed in this administrative record.
No comparator, control group, or patient outcomes are reported.
This is a regulatory administrative action only; it does not constitute evidence of clinical benefit or harm.

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, not a clinical study; no trial design present.

Directness

insufficient

Labeling action only; no clinical outcome data reported.

Consistency

insufficient

No comparative data or prior results cited in this record.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No patient population or sample size described in this action.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA076356. This is a regulatory action record, not a clinical study. Brand name: CLARAVIS. Active ingredient: ISOTRETINOIN. Sponsor: TEVA PHARMS USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-21. Products: CLARAVIS, CAPSULE, ORAL, ISOTRETINOIN 10MG.

Follow from this

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

IsotretinoinTeva Pharms U