- FDA approves Plan B One-Step OTC switch
- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- FDA issues sweeping new requirements for long-acting opioids
- Federal government must find alternatives to rescheduling hydrocodone combination drugs
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.
The FDA announced the approval of Novartis' Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.
NTDT is a mild form of thalassemia that, unlike the more severe form of the disease, does not require frequent red blood cell transfusions. However, both disorders cause iron overload that can damage vital organs. According to the National Heart, Lung and Blood Institute, part of the National Institutes of Health, about 1,000 people in the United States have thalassemia.
The drug was previously approved for treating chronic iron overload due to blood transfusions in patients ages 2 years and older.