Nplate FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 15, 2019.
FDA Approved: Yes (First approved August 22, 2008)
Brand name: Nplate
Generic name: romiplostim
Company: Amgen Inc.
Treatment for: Idiopathic Thrombocytopenic Purpura
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Nplate is indicated for the treatment of thrombocytopenia in:
- Adult patients with immune thrombocytopenia (ITP) who have had an 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.
Development Timeline for Nplate
|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|
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