Pazopanib

FDA Drug Profile — Pazopanib

Drug Details

Generic Name
Pazopanib
Brand Names
Pazopanib
Application Number
ANDA215837
Sponsor
SUN PHARMACEUTICAL INDUSTRIES, INC.
NDC Codes
6
Dosage Forms
TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
PAZOPANIB HYDROCHLORIDE, PAZOPANIB

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.