Eltrombopag Olamine · Regulatory approval

FDA approval: Eltrombopag Olamine

U.S. Food and Drug Administration · April 28, 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 eltrombopag olamine formulation (ANDA220660) by Biocon Pharma on 28 April 2026 in four tablet strengths (12.5, 25, 50, and 75 mg). This is a regulatory action documenting bioequivalence and manufacturing compliance; it does not contain or summarize clinical efficacy, safety, or comparative trial data.

What was studied

Regulatory approval.

Key findings

Approval granted for eltrombopag olamine tablet formulations in strengths 12.5 mg, 25 mg, 50 mg, and 75 mg acid equivalents

Safety

This regulatory record does not report clinical trial efficacy, safety outcomes, or comparative effectiveness data. No study population, sample size, or adverse event data are reported.

Who this may help

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

Plain-language summary

FDA approval of a generic eltrombopag olamine formulation; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative benefit data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-28

Application typeANDA (Abbreviated New Drug Application)

SponsorBIOCON PHARMA

Tablet strengths approved12.5 mg, 25 mg, 50 mg, 75 mg

Caveats

This regulatory record does not report clinical trial efficacy, safety outcomes, or comparative effectiveness data.
ANDA approval is based on bioequivalence to a reference product; efficacy data are not contained in this record.
No study population, sample size, or adverse event data are reported.
Record does not specify indications or dosing recommendations; refer to the approved label.

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

This is a regulatory approval record, not a clinical study.

Directness

insufficient

Regulatory record does not report clinical outcomes or trial data.

Consistency

insufficient

Record does not compare outcomes across studies or populations.

Risk of bias

insufficient

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

Sample adequacy

insufficient

No clinical trial sample size or study population reported.

Source abstract

Drugs@FDA record for application ANDA220660. This is a regulatory action record, not a clinical study. Brand name: ELTROMBOPAG OLAMINE. Active ingredient: ELTROMBOPAG OLAMINE. Sponsor: BIOCON PHARMA. Submission type: ORIG (original application). Approval status date: 2026-04-28. Products: ELTROMBOPAG OLAMINE, TABLET, ORAL, ELTROMBOPAG OLAMINE EQ 50MG ACID; ELTROMBOPAG OLAMINE, TABLET, ORAL, ELTROMBOPAG OLAMINE EQ 12.5MG ACID; ELTROMBOPAG OLAMINE, TABLET, ORAL, ELTROMBOPAG OLAMINE EQ 75MG ACID; ELTROMBOPAG OLAMINE, TABLET, ORAL, ELTROMBOPAG OLAMINE EQ 25MG ACID.

Follow from this

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

Biocon PharmaEltrombopag Olamine