Promacta Kit

Treats thrombocytopenia. NDA 207027, held by Novartis. Eltrombopag Olamine.

As of Nov 14, 2026, NDA 207027 (Promacta Kit), held by Novartis, was first approved by FDA on Aug 24, 2015, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2015
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Aug 24, 2015	Original applicationTYPE 3/4 · Priority review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Promacta KitEQ 25MG ACID/PACKET · for suspension;oral	Eltrombopag Olamine	RxReference drug
Promacta KitEQ 12.5MG ACID/PACKET · for suspension;oral	Eltrombopag Olamine	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 6, 2025	Supplement 20Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 9, 2023	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 31, 2022	Supplement 15Labeling · Standard review	Approved	Label Letter
Feb 3, 2021	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 8, 2020	Supplement 13Manufacturing	Approved	Label Letter
Apr 29, 2020	Supplement 10Labeling · Standard review	Approved	Label Letter
Apr 24, 2019	Supplement 8Labeling · Standard review	Approved	Label
Sep 27, 2018	Supplement 6Labeling · Standard review	Approved	Label Letter Pediatric Medical Review
Jul 24, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label
May 25, 2018	Supplement 4Labeling · Standard review	Approved	Label Letter
Jul 5, 2017	Supplement 3Labeling · Standard review	Approved	Label
Mar 9, 2017	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 12, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Aug 24, 2015	Original applicationTYPE 3/4 · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 207027
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters