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
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