Treats chronic iron overload due to blood transfusions. ANDA 215137, held by Aurobindo Pharma. Deferasirox.
As of Nov 15, 2026, ANDA 215137 (Deferasirox), held by Aurobindo Pharma, was first approved by FDA on Sep 8, 2025, with 0 approved supplements and 0 published complete response letters.
Deferasirox oral granules are iron chelators indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2025 | Original application | Approved | None posted |
| Deferasirox90MG · granule;oral | Deferasirox | Rx |
| Deferasirox180MG · granule;oral | Deferasirox | Rx |
| Deferasirox360MG · granule;oral | Deferasirox | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
