Treats thrombocytopenia. BLA 125268, held by Amgen. Romiplostim.
As of Nov 13, 2026, BLA 125268 (Nplate), held by Amgen, was first approved by FDA on Aug 22, 2008, with 20 approved supplements and 0 published complete response letters.
Nplate is a thrombopoietin receptor agonist 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. 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]).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2021 | Supplement 167Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2019 | Supplement 164Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2018 | Supplement 163Efficacy (new indication or use) · Priority review | Approved | |
| Aug 22, 2008 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nplate250MCG/0.5ML; 500MCG/1ML. · injectable; subcutaneous | Romiplostim | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2025 | Supplement 176Labeling · Standard review | Approved | |
| Feb 10, 2022 | Supplement 172Labeling · Standard review | Approved | |
| Feb 10, 2021 | Supplement 168Labeling · Standard review | Approved | |
| Jan 29, 2021 | Supplement 170REMS | Approved | |
| Jan 28, 2021 | Supplement 167Efficacy (new indication or use) · Priority review | Approved | |
| Nov 23, 2020 | Supplement 169Labeling · Standard review | Approved | |
| Oct 17, 2019 | Supplement 164Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2018 | Supplement 163Efficacy (new indication or use) · Priority review | Approved | |
| Jun 5, 2017 | Supplement 160Labeling · Standard review | Approved | |
| Apr 19, 2016 | Supplement 156Labeling · Standard review | Approved | |
| Apr 19, 2016 | Supplement 155Labeling · Standard review | Approved | |
| Feb 10, 2014 | Supplement 141Labeling · Standard review | Approved | |
| May 30, 2013 | Supplement 121Labeling · Standard review | Approved | |
| Nov 2, 2012 | Supplement 106Labeling · Standard review | Approved | |
| Dec 6, 2011 | Supplement 77Labeling · Standard review | Approved | |
| Jun 21, 2011 | Supplement 73Labeling · Standard review | Approved | None posted |
| Mar 23, 2010 | Supplement 36 | Approved | |
| Mar 23, 2010 | Supplement 28 | Approved | |
| Sep 18, 2009 | Supplement 32 | Approved | None posted |
| Aug 14, 2009 | Supplement 26Labeling · Standard review | Approved | |
| Aug 22, 2008 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
