Ramelteon · Regulatory approval

FDA approval: Ramelteon

U.S. Food and Drug Administration · June 4, 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 ramelteon 8 mg tablet (ANDA215485) from Hibrow Healthcare on 4 June 2026. This is a regulatory action record documenting approval of a bioequivalent formulation; it does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory approval. Intervention: Ramelteon 8 mg tablet, oral.

Key findings

FDA approval granted for ramelteon 8 mg oral tablet (ANDA215485) on approval status date 2026-06-04

Safety

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

Who this may help

This approval authorises generic distribution of ramelteon 8 mg; clinicians should refer to the approved product labelling and the original drug application for efficacy and safety information. Generic approval indicates bioequivalence to the reference product but does not reflect new clinical evidence.

Plain-language summary

FDA approval of a generic ramelteon formulation; this is a regulatory action, not a clinical evidence trial, and does not report efficacy or safety data.

Study design

As stated by the source record.

InterventionRamelteon 8 mg tablet, oral

Reported figures

Quoted from the source exactly as published.

Approved dose strength8 mg

Approval date2026-06-04

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy outcomes, or safety data.
Sample size, study design, and population characteristics are not reported.
Bioequivalence data from the ANDA submission are not disclosed in this regulatory record.
No comparator or comparative clinical outcome data are present.

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 documents approval action only; no clinical outcomes reported.

Consistency

insufficient

No comparative data or multiple studies presented in this record.

Risk of bias

insufficient

Regulatory approval record does not include trial methodology or bias assessment.

Sample adequacy

insufficient

No patient population or sample size data in this approval record.

Source abstract

Drugs@FDA record for application ANDA215485. This is a regulatory action record, not a clinical study. Brand name: RAMELTEON. Active ingredient: RAMELTEON. Sponsor: HIBROW HLTHCARE. Submission type: ORIG (original application). Approval status date: 2026-06-04. Products: RAMELTEON, TABLET, ORAL, RAMELTEON 8MG.

Follow from this

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

RamelteonHibrow Hlthcare