deferiprone

FDA Drug Profile — DEFERIPRONE, FERRIPROX

deferiprone is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including DEFERIPRONE, FERRIPROX. Available dosage forms: tablet, coated, solution, tablet.

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 Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. ( 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. Pediatric use information is approved for Chiesi USA, Inc.'s FERRIPROX ® (deferiprone) tablets. However, due to Chiesi USA, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.