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As of Nov 15, 2026, ANDA 216620 (Eltrombopag Olamine), held by Annora Pharma, was first approved by FDA on Apr 18, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Apr 18, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Eltrombopag for oral suspension 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 for oral suspension 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.
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
