Treats thrombocytopenia. ANDA 219121, held by Dr Reddys. Eltrombopag Olamine, Eltrombopag.
As of Nov 15, 2026, ANDA 219121 (Eltrombopag Olamine, Eltrombopag), held by Dr Reddys, was first approved by FDA on Mar 16, 2026, with 0 approved supplements and 0 published complete response letters.
Eltrombopag is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2026 | Original application | Approved | None posted |
| Eltrombopag OlamineEQ 12.5MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
| Eltrombopag OlamineEQ 25MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
| Eltrombopag OlamineEQ 50MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
| Eltrombopag OlamineEQ 75MG ACID · tablet;oral | Eltrombopag Olamine | Rx |
| Eltrombopag25MG · tablet | Eltrombopag | None (tentative approval) |
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
