deferasirox
deferasirox is listed in the FDA National Drug Code directory with 28 NDC codes, marketed under brand names including deferasirox, Deferasirox Oral Granules, Jadenu. Available dosage forms: tablet, for suspension, granule, tablet, film coated, powder.
Drug Details
- Generic Name
- deferasirox
- Brand Names
- deferasirox, Deferasirox Oral Granules, Jadenu, Deferasirox, Exjade
- Application Number
- ANDA209433
- Sponsor
- Glenmark Pharmaceuticals Inc., USA
- NDC Codes
- 28
- Dosage Forms
- TABLET, FOR SUSPENSION, GRANULE, TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- DEFERASIROX
Indications and Usage
1 INDICATIONS AND USAGE Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. 1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. 1.3 Limitations of Use The safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established.