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FDA BLA · BLA125268

NPLATE

romiplostim

Sponsor: AMGEN

APPLICATION
BLA125268
TYPE
BLA
ORIGINAL APPROVAL
2008-08-22
LATEST ACTION
2025-02-21
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NPLATEPrescription
ROMIPLOSTIM 250MCG/0.5ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-02-21Labeling · Supplement 176 · standard — Label ↗AP
2022-02-10Labeling · Supplement 172 · standard — Label ↗AP
2021-02-10Labeling · Supplement 168 · standard — Letter ↗AP
2021-01-29REMS · Supplement 170 — Letter ↗AP
2021-01-28Efficacy · Supplement 167 · priority — Label ↗AP
2020-11-23Labeling · Supplement 169 · standard — Label ↗AP
2019-10-17Efficacy · Supplement 164 · standard — Label ↗AP
2018-12-14Efficacy · Supplement 163 · priority — Label ↗AP
2017-06-05Labeling · Supplement 160 · standard — Letter ↗AP
2016-04-19Labeling · Supplement 155 · standard — Label ↗AP
2016-04-19Labeling · Supplement 156 · standard — Letter ↗AP
2014-02-10Labeling · Supplement 141 · standard — Label ↗AP
2013-05-30Labeling · Supplement 121 · standard — Label ↗AP
2012-11-02Labeling · Supplement 106 · standard — Label ↗AP
2011-12-06Labeling · Supplement 77 · standard — Label ↗AP
2011-06-21Labeling · Supplement 73 · standardAP
2010-03-23Supplement · Supplement 36 — Letter ↗AP
2010-03-23Supplement · Supplement 28 — Letter ↗AP
2009-09-18Supplement · Supplement 32AP
2009-08-14Labeling · Supplement 26 · standard — Label ↗AP
2008-08-22Type 1 - New Molecular Entity · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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