← FDA DRUG APPROVALS

FDA BLA · BLA125320

PROLIA

denosumab

Sponsor: AMGEN

APPLICATION
BLA125320
TYPE
BLA
ORIGINAL APPROVAL
2010-06-01
LATEST ACTION
2026-06-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PROLIAPrescription
DENOSUMAB 60MG/ML · INJECTABLE · SUBCUTANEOUS
XGEVAPrescription
DENOSUMAB 70MG/ML · INJECTABLE · SUBCUTANEOUS

Approval history

2026-06-23Labeling · Supplement 225 · standard — Letter ↗AP
2026-06-23Labeling · Supplement 224 · standard — Letter ↗AP
2025-05-30Labeling · Supplement 222 · standard — Letter ↗AP
2025-05-22Efficacy · Supplement 219 · standard — Letter ↗AP
2025-04-28Manufacturing (CMC) · Supplement 221 — Letter ↗AP
2024-04-09REMS · Supplement 218 — Letter ↗AP
2024-03-05REMS · Supplement 217 — Letter ↗AP
2024-03-05Efficacy · Supplement 213 · standard — Letter ↗AP
2024-01-19Labeling · Supplement 216 · standard — Label ↗AP
2023-01-03Labeling · Supplement 211 · standard — Letter ↗AP
2022-05-19Labeling · Supplement 210 · standard — Label ↗AP
2021-05-12Labeling · Supplement 207 · standard — Letter ↗AP
2020-06-09Efficacy · Supplement 203 · standard — Letter ↗AP
2020-04-23Labeling · Supplement 205 · standard — Label ↗AP
2020-02-10Labeling · Supplement 201 · standard — Letter ↗AP
2019-10-01Labeling · Supplement 202 · standard — Label ↗AP
2019-07-26Labeling · Supplement 198 · standard — Label ↗AP
2019-05-24Labeling · Supplement 195 · standard — Label ↗AP
2019-05-08Labeling · Supplement 196 · standard — Letter ↗AP
2019-05-08Labeling · Supplement 199 · standard — Letter ↗AP
2019-04-30Labeling · Supplement 200 · standard — Label ↗AP
2018-06-07Labeling · Supplement 191 · standard — Label ↗AP
2018-05-18Efficacy · Supplement 186 · standard — Letter ↗AP
2018-01-24Labeling · Supplement 185 · standard — Letter ↗AP
2018-01-04Efficacy · Supplement 182 · standard — Letter ↗AP
2017-05-26Efficacy · Supplement 181 · standard — Letter ↗AP
2017-01-31Labeling · Supplement 180 · standard — Letter ↗AP
2016-08-05Labeling · Supplement 178 · standard — Letter ↗AP
2016-03-02Labeling · Supplement 177 · standard — Label ↗AP
2015-06-08Labeling · Supplement 168 · standard — Label ↗AP
2015-05-21REMS · Supplement 162 — Letter ↗AP
2015-04-08Labeling · Supplement 174 · standard — Label ↗AP
2015-02-26Labeling · Supplement 170 · standard — Label ↗AP
2014-12-05Efficacy · Supplement 160 · priority — Label ↗AP
2014-06-16Labeling · Supplement 150 · standard — Label ↗AP
2014-06-04Labeling · Supplement 155 · standard — Letter ↗AP
2013-08-23Labeling · Supplement 124 · standard — Label ↗AP
2013-08-23Labeling · Supplement 114 · standard — Label ↗AP
2013-07-03Labeling · Supplement 113 · standard — Label ↗AP
2013-06-13Efficacy · Supplement 94 · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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