pazopanib hydrochloride

FDA Drug Profile — pazopanib, VOTRIENT

pazopanib hydrochloride is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including pazopanib, VOTRIENT. Available dosage form: tablet, film coated.

Drug Details

Generic Name
pazopanib hydrochloride
Brand Names
pazopanib, VOTRIENT
Application Number
ANDA218231
Sponsor
Novugen Pharma (USA) LLC.
NDC Codes
5
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
PAZOPANIB HYDROCHLORIDE

Indications and Usage

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