Treats thrombocytopenia. NDA 216774, held by Teva Pharms Inc. Eltrombopag Choline.
As of Nov 14, 2026, NDA 216774 (Alvaiz), held by Teva Pharms Inc, was first approved by FDA on Nov 29, 2023, with 1 approved supplement and 0 published complete response letters.
ALVAIZ is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ 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 adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2023 | Original applicationNew active ingredient · Standard review | Approved |
| AlvaizEQ 9MG BASE · tablet;oral | Eltrombopag Choline | RxReference drug |
| AlvaizEQ 18MG BASE · tablet;oral | Eltrombopag Choline | RxReference drug |
| AlvaizEQ 36MG BASE · tablet;oral | Eltrombopag Choline | RxReference drug |
| AlvaizEQ 54MG BASE · tablet;oral | Eltrombopag Choline | RxReference drug |
| Jan 15, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Nov 29, 2023 | Original applicationNew active ingredient · Standard review | Approved |
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
