pexidartinib hydrochloride

FDA Drug Profile — Turalio

Drug Details

Generic Name
pexidartinib hydrochloride
Brand Names
Turalio
Application Number
NDA211810
Sponsor
Daiichi Sankyo Inc.
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
PEXIDARTINIB HYDROCHLORIDE

Indications and Usage

1 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. TURALIO is a kinase inhibitor 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. ( 1 )