sorafenib

FDA Drug Profile — sorafenib, Nexavar, Sorafenib

sorafenib is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including sorafenib, Nexavar, Sorafenib. Available dosage form: tablet, film coated.

Drug Details

Generic Name
sorafenib
Brand Names
sorafenib, Nexavar, Sorafenib
Application Number
ANDA216073
Sponsor
Dr.Reddys Laboratories Inc
NDC Codes
9
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
SORAFENIB TOSYLATE, SORAFENIB

Indications and Usage

Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma(1.1) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.