Turalio

Treats symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity…. NDA 211810, held by Daiichi Sankyo Inc. Pexidartinib Hydrochloride.

As of Nov 14, 2026, NDA 211810 (Turalio), held by Daiichi Sankyo Inc, was first approved by FDA on Aug 2, 2019, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2019
Review: Priority
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Oct 14, 2022	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 6, 2022	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter
Aug 2, 2019	Original applicationNew molecular entity · Priority review	Approved	REMS Review Letter Label

Products

2 strengths and forms


TuralioEQ 200MG BASE · capsule;oral	Pexidartinib Hydrochloride	DiscontinuedReference drug
TuralioEQ 125MG BASE · capsule;oral	Pexidartinib Hydrochloride	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Aug 27, 2025	Supplement 14REMS	Approved	Letter
Jan 3, 2025	Supplement 13Labeling · Standard review	Approved	Medication Guide Letter Label
Nov 16, 2023	Supplement 12Labeling · Standard review	Approved	Label Letter
Apr 17, 2023	Supplement 11REMS	Approved	None posted
Oct 14, 2022	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 6, 2022	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter
Jul 14, 2022	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 20, 2021	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 16, 2020	Supplement 6REMS	Approved	Letter Letter
Aug 4, 2020	Supplement 5REMS	Approved	Letter
Apr 17, 2020	Supplement 3Labeling · Standard review	Approved	Label Letter
Apr 10, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Nov 19, 2019	Supplement 2REMS	Approved	Letter
Nov 19, 2019	Supplement 1REMS	Approved	Letter
Aug 2, 2019	Original applicationNew molecular entity · Priority review	Approved	REMS Review Letter Label

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: TURALIONov 24, 2025

Identifiers

Application: NDA 211810
Drugs@FDA: Overview at FDA
Company: Daiichi Sankyo

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