deferiprone

FDA Drug Profile — DEFERIPRONE, FERRIPROX

Drug Details

Generic Name
deferiprone
Brand Names
DEFERIPRONE, FERRIPROX
Application Number
ANDA220132
Sponsor
DR. REDDY'S LABORATORIES, INC.
NDC Codes
4
Dosage Forms
TABLET, COATED, SOLUTION, TABLET
Routes
ORAL
Active Ingredients
DEFERIPRONE

Indications and Usage

1 INDICATIONS AND USAGE FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. FERRIPROX Oral Solution is an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. ( 1 ) Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.