Eltrombopag Olamine · Regulatory approval

FDA approval: Eltrombopag Olamine

U.S. Food and Drug Administration · June 17, 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 an abbreviated new drug application (ANDA) for eltrombopag olamine 50 mg tablet on 17 June 2026. This is a regulatory action confirming bioequivalence and manufacturing compliance for a generic formulation; it does not report clinical efficacy, safety trial results, or comparative effectiveness data.

What was studied

Regulatory approval. Intervention: Eltrombopag olamine 50 mg tablet, oral formulation.

Key findings

ANDA208815 for eltrombopag olamine 50 mg tablet approved on 2026-06-17

Safety

This record does not contain clinical trial results, efficacy data, safety endpoints, or comparative effectiveness information. No adverse event data, contraindications, or dosing guidance provided in this regulatory action.

Who this may help

This approval allows marketing of a generic eltrombopag olamine formulation. Clinicians should refer to the approved label and the established reference product safety and efficacy profile for clinical guidance; this regulatory record does not itself describe clinical outcomes or comparative benefit.

Plain-language summary

FDA approval of an ANDA application for eltrombopag olamine generic formulation; regulatory action rather than clinical evidence of efficacy or comparative benefit.

Study design

As stated by the source record.

InterventionEltrombopag olamine 50 mg tablet, oral formulation

Reported figures

Quoted from the source exactly as published.

Approved strength50 mg

Approval date2026-06-17

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety endpoints, or comparative effectiveness information.
No bioequivalence study details, sample size, or statistical analysis reported in this approval notice.
No adverse event data, contraindications, or dosing guidance provided in this regulatory action.

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 does not describe clinical outcomes or patient populations studied.

Consistency

insufficient

No comparative data or prior studies referenced in this approval record.

Risk of bias

insufficient

Regulatory action; no trial conduct or bias assessment disclosed.

Sample adequacy

insufficient

No sample size or study population data provided in approval notice.

Source abstract

Drugs@FDA record for application ANDA208815. This is a regulatory action record, not a clinical study. Brand name: ELTROMBOPAG OLAMINE. Active ingredient: ELTROMBOPAG OLAMINE. Sponsor: ACTAVIS LABS FL. Submission type: ORIG (original application). Approval status date: 2026-06-17. Products: ELTROMBOPAG OLAMINE, TABLET, ORAL, ELTROMBOPAG OLAMINE EQ 50MG ACID.

Follow from this

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

Actavis Labs FLEltrombopag Olamine