Nplate FDA Approval History
Last updated by Judith Stewart, BPharm on April 1, 2025.
FDA Approved: Yes (First approved August 22, 2008)
Brand name: Nplate
Generic name: romiplostim
Company: Amgen Inc.
Treatment for: Immune Thrombocytopenia, Hematopoietic Syndrome of Acute Radiation Syndrome
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of immune thrombocytopenia and Hematopoietic Syndrome of Acute Radiation Syndrome.
- Nplate is indicated for the treatment of thrombocytopenia in:
- adult patients with immune thrombocytopenia (ITP) who have had insufficient response to corticosteroids, immunoglobulins, or splenectomy.
- pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. - Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]).
Development timeline for Nplate
| Date | Article |
|---|---|
| Oct 18, 2019 | Approval Nplate (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia |
| Dec 14, 2018 | Approval FDA Approves Nplate (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia |
| Aug 22, 2008 | Approval FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP |
| Jul 15, 2008 | Amgen's FDA Nplate Approval Statement Retracted |
| Jul 14, 2008 | FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP |
| Mar 13, 2008 | Amgen Statement on Successful Outcome of Romiplostim Panel Meeting |
| Mar 12, 2008 | Amgen to Discuss Romiplostim Application at FDA ODAC Meeting |
Further information
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