Treats thrombocytopenia. ANDA 208815, held by Actavis Labs Fl. Eltrombopag Olamine.
As of Nov 15, 2026, ANDA 208815 (Eltrombopag Olamine), held by Actavis Labs Fl, was first approved by FDA on Jun 17, 2026, with 0 approved supplements and 0 published complete response letters.
Eltrombopag tablets are a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon- based therapy. in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Eltrombopag OlamineEQ 50MG ACID · tablet;oral | Eltrombopag Olamine | 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
