Trade name: Jadenu
Generic name: Deferasirox
Application number (NDA): 206910
Approval date: March 30, 2015
Jadenu is a new drug which is approved as an iron chelator and used for the treatment of chronic iron overload due to the transfusion of blood. This drug is approved for reducing the iron concentration in liver and serum ferritin levels. It is used for chronic excessive iron in liver in the patients who are 10 years and older and suffering from Non Transfusion Dependent Thalassemia syndrome in which iron and serum ferritin gets overloaded in the liver and can cause toxicity. It is also used in patient suffering from sickle cell diseases.
Approval Details: This drug is manufactured by Novartis Pharmaceutical Cooperation (Oncology Department). The New Drug Application was submitted under section 505b of Federal Food, Drug and Cosmetic Act on May 30th, 2014. FDA approved the product under accelerated approval regulations 21 CFR314.510 and requested further clinical trials and well controlled studies to explain the clinical benefit of this drug. FDA also requested to submit the post marketing requirements under section 505 (o) and the promotional material.
Dosage and Administration: Initial dose is 14 mg/kg for transfusion iron overdose and …show more content…
There are no clinical trials in the patients with this drug, but it contains the same active ingredient as Exjade tablets for oral suspension. Clinical trials are performed for Trans fusional iron overload and for Non Trans fusional Dependent Thalassemia(NTDT) with Exjade. Trans fusional iron is the primary study which are open label, randomized study compared with patients suffering from beta thalassemia and also from trans fusional hemosiderosis.In Non Trans fusional Dependent Thalassemia study was randomized, double blind and placebo control performed with deferasirox tablets with patients who are 10 year older or suffering from NTDT syndromes and overload of