Estradiol · Regulatory label update

FDA supplemental approval: Estradiol (Labeling)

U.S. Food and Drug Administration · June 8, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval action for estradiol transdermal film formulations in four dose strengths (0.025, 0.05, 0.06, and 0.1 mg/24 hr), issued by Mylan Technologies on 8 June 2026. The record documents a labeling change only and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

FDA supplemental approval issued 8 June 2026 for estradiol transdermal film labeling (Mylan Technologies, ANDA075182) Four dose strengths approved: 0.025 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, and 0.1 mg/24 hr

Safety

The submission class is 'Labeling' only; no new safety or efficacy studies are reported. No information on indication, contraindications, adverse events, or clinical outcomes is provided in this regulatory record.

Who this may help

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

Plain-language summary

FDA supplemental approval of estradiol transdermal film labeling; a regulatory action that does not report clinical trial outcomes or comparative efficacy data.

Caveats

This record does not contain clinical trial results, efficacy data, or comparative evidence.
The submission class is 'Labeling' only; no new safety or efficacy studies are reported.
No information on indication, contraindications, adverse events, or clinical outcomes is provided in this regulatory record.
The approval date (2026-06-08) may be prospective or hypothetical relative to the query date.

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 action; no clinical study design reported.

Directness

insufficient

Record does not contain clinical trial data or efficacy endpoints.

Consistency

insufficient

No comparative or replication data provided in this record.

Risk of bias

insufficient

Not applicable; regulatory labeling record without trial methodology.

Sample adequacy

insufficient

No human subjects or sample size reported in labeling action.

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

Source abstract

Drugs@FDA record for application ANDA075182. This is a regulatory action record, not a clinical study. Brand name: ESTRADIOL. Active ingredient: ESTRADIOL. Sponsor: MYLAN TECHNOLOGIES. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-08. Products: ESTRADIOL, FILM, EXTENDED RELEASE, TRANSDERMAL, ESTRADIOL 0.06MG/24HR; ESTRADIOL, FILM, EXTENDED RELEASE, TRANSDERMAL, ESTRADIOL 0.025MG/24HR; ESTRADIOL, FILM, EXTENDED RELEASE, TRANSDERMAL, ESTRADIOL 0.1MG/24HR; ESTRADIOL, FILM, EXTENDED RELEASE, TRANSDERMAL, ESTRADIOL 0.05MG/24HR.

Follow from this

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

Mylan TechnologiesEstradiol