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Nplate FDA Approval History

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

DateArticle
Oct 18, 2019Approval Nplate (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
Dec 14, 2018Approval FDA Approves Nplate (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia
Aug 22, 2008Approval FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
Jul 15, 2008Amgen's FDA Nplate Approval Statement Retracted
Jul 14, 2008FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
Mar 13, 2008Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
Mar 12, 2008Amgen to Discuss Romiplostim Application at FDA ODAC Meeting

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.