Vimseltinib

FDA Drug Profile — ROMVIMZA

Drug Details

Generic Name
Vimseltinib
Brand Names
ROMVIMZA
Application Number
NDA219304
Sponsor
Deciphera Pharmaceuticals, LLC
NDC Codes
3
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
VIMSELTINIB

Indications and Usage

1 INDICATIONS AND USAGE ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )