deferiprone
Drug Details
- Generic Name
- deferiprone
- Brand Names
- FERRIPROX, DEFERIPRONE
- Application Number
- NDA212269
- Sponsor
- Chiesi USA, Inc.
- NDC Codes
- 5
- Dosage Forms
- TABLET, TABLET, COATED, TABLET, FILM COATED, SOLUTION
- 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. 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. 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.