Drugs / Desferasirox
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | Jadenu | — | 2015-03-30 | “Novartis has submitted additional regulatory applications for Jadenu in other countries worldwide.” novartis.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01546415 | Oct 2011 → Nov 2013 | disorder of iron metabolism and transport | Novartis Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-11-16 | Novartis Pharmaceuticals | Results Novartis data at ASH and SABCS showcase latest innovations in development for patients with blood disorders and breast cancer novartis.com ↗
New Film-Coated Tablet Formulation of Deferasirox is Well Tolerated in Patients with Thalassemia or MDS: Results of the Randomized, Phase II ECLIPSE Study |
| 2015-03-30 | Novartis Pharmaceuticals | Regulatory Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload novartis.com ↗
Jadenu is approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-11-16 | Novartis Pharmaceuticals | Novartis data at ASH and SABCS showcase latest innovations in development for patients with blood disorders and breast cancer novartis.com ↗ |
| 2015-03-30 | Novartis Pharmaceuticals | Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload novartis.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Desferasirox | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01546415 ↗ |
| Known as | deferasirox | “Efficacy and safety of deferasirox in aplastic anemia patients with iron overload: a single arm, multi-center,prospective study in China” PMID 26876245 ↗ Jan 2016 |