Eltrombopag Olamine

Treats thrombocytopenia. Sold as Promacta. Every FDA application for this active ingredient: 2 branded and 12 generic.

As of Nov 15, 2026, FDA lists 14 applications for Eltrombopag Olamine (sold as Promacta), first approved Nov 20, 2008, with 5 new uses approved and 0 published complete response letters.

First approved: Nov 20, 2008
Applications: 14
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $865M
First approved in the EU: Mar 11, 2010
First approved in Japan: Oct 27, 2010

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Promacta	Part D	$690M	+3%	7,391
Eltrombopag Olamine	Part D	$175M	New	4,178

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ELTROMBOPAG 50 MG TABLET: $25.85 per unitGeneric · new this year

Orphan Designations (FDA)

3 designations, 3 approved for the designated use; see all orphan designations

Treatment of aplastic anemiaNovartis Pharmaceuticals Corp. · designated Nov 8, 2013 · approved Aug 26, 2014
Treatment of aplastic anemiaNovartis Pharmaceuticals Corp. · designated Nov 8, 2013 · approved Nov 16, 2018
Treatment of idiopathic thrombocytopenia purpuraNovartis Pharmaceuticals Corp. · designated May 5, 2008 · approved Nov 20, 2008

Approvals in the EU (EMA)

First approved in the EU 16 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Eltrombopag Accord, genericAccord Healthcare S.L.U. · Mar 28, 2025
Eltrombopag Viatris, genericViatris Limited · Dec 12, 2024
Revolade, new substanceNovartis Europharm Limited · Mar 11, 2010

Approvals in Japan (PMDA)

First approved in Japan 23 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

RevoladeDrugs with a new additional pediatric dosage indicated for the treatment of chronic idiopathic thrombocytopenic purpura. · Novartis Pharma K.K. · Nov 22, 2024
RevoladeDrugs with a new additional pediatric dosage indicated for the treatment of aplastic anemia. · Novartis Pharma K.K. · Dec 22, 2023
RevoladeDrugs with a new additional indication and a new dosage for the treatment of aplastic anemia. · Novartis Pharma K.K. · Aug 25, 2017 · Review report
Revolade, new ingredientDrugs with a new active ingredient indicated for the treatment of chronic idiopathic thrombocytopenic purpura. · GlaxoSmithKline K.K. · Oct 27, 2010 · Review report

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Primary Prevention of Thrombocytopenia Associated With T-DM1 Therapy in HER2 Positive Breast Cancer With HerombopagHER2-positive Breast Cancer · Zhenzhen Liu	Not applicable	Not yet recruiting	Sep 30, 2025
Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITPPrimary Immune Thrombocytopenia (ITP) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Phase 4	Not yet recruiting	Sep 24, 2025
Study on the Short-term Efficacy and Safety of Recombinant Human Thrombopoietin Combined With Immunosuppressant Sequential Eltrombopag Ethanolamine Dry Suspension in the Treatment of SAA/TD-NSAAAplastic Anemias · Peking Union Medical College Hospital	Phase 3	Not yet recruiting	Jun 3, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 20, 2008	PromactaNDA 22291 · New molecular entity	Novartis	25	Marketed
Aug 24, 2015	PromactaNDA 207027 · TYPE 3/4	Novartis	13	Marketed
Apr 18, 2024	Eltrombopag OlamineANDA 216620	Annora Pharma	0	Marketed
Jan 17, 2025	Eltrombopag OlamineANDA 206788	Hetero Labs Ltd V	0	Marketed
Jan 14, 2026	Eltrombopag OlamineANDA 212884	Amneal	0	Marketed
Jan 14, 2026	Eltrombopag OlamineANDA 216281	Zydus Pharms	0	Marketed
Jan 14, 2026	Eltrombopag OlamineANDA 219638	Somerset Theraps LLC	0	Marketed
Jan 14, 2026	Eltrombopag OlamineANDA 220250	Msn	0	Marketed
Mar 16, 2026	Eltrombopag Olamine, EltrombopagANDA 219121	Dr Reddys	0	Marketed
Apr 8, 2026	Eltrombopag OlamineANDA 220033	Hikma	0	Marketed
Apr 28, 2026	Eltrombopag OlamineANDA 220660	Biocon Pharma	0	Marketed
Jun 17, 2026	Eltrombopag OlamineANDA 208815	Actavis Labs Fl	0	Marketed
Jul 13, 2026	Eltrombopag OlamineANDA 209938	Teva Pharms USA	0	Marketed
Nov 5, 2026	Eltrombopag OlamineANDA 221019	Changzhou Pharm	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA