pazopanib hydrochloride

FDA Drug Profile — VOTRIENT, pazopanib

Drug Details

Generic Name
pazopanib hydrochloride
Brand Names
VOTRIENT, pazopanib
Application Number
NDA022465
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
5
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
PAZOPANIB HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use: The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma Pazopanib tablets are indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use: The efficacy of pazopanib tablets for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.