Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2025 | Supplement 219Efficacy (new indication or use) · Standard review | Approved | |
| Mar 5, 2024 | Supplement 213Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2020 | Supplement 203Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2018 | Supplement 186Efficacy (new indication or use) · Standard review | Approved | |
| Jan 4, 2018 | Supplement 182Efficacy (new indication or use) · Standard review | Approved | |
| May 26, 2017 | Supplement 181Efficacy (new indication or use) · Standard review | Approved | |
| Dec 5, 2014 | Supplement 160Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2013 | Supplement 94Efficacy (new indication or use) · Priority review | Approved | |
| Sep 20, 2012 | Supplement 51Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2010 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jun 1, 2010 | Original applicationNew molecular entity · Standard review | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2026 | Supplement 224Labeling · Standard review | Approved | |
| Jun 23, 2026 | Supplement 225Labeling · Standard review | Approved | |
| May 30, 2025 | Supplement 222Labeling · Standard review | Approved | |
| May 22, 2025 | Supplement 219Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2025 | Supplement 221Manufacturing | Approved | |
| Apr 9, 2024 | Supplement 218REMS | Approved | |
| Mar 5, 2024 | Supplement 213Efficacy (new indication or use) · Standard review | Approved | |
| Mar 5, 2024 | Supplement 217REMS | Approved | |
| Jan 19, 2024 | Supplement 216Labeling · Standard review | Approved | |
| Jan 3, 2023 | Supplement 211Labeling · Standard review | Approved | |
| May 19, 2022 | Supplement 210Labeling · Standard review | Approved | |
| May 12, 2021 | Supplement 207Labeling · Standard review | Approved | |
| Jun 9, 2020 | Supplement 203Efficacy (new indication or use) · Standard review | Approved | |
| Apr 23, 2020 | Supplement 205Labeling · Standard review | Approved | |
| Feb 10, 2020 | Supplement 201Labeling · Standard review | Approved | |
| Oct 1, 2019 | Supplement 202Labeling · Standard review | Approved | |
| Jul 26, 2019 | Supplement 198Labeling · Standard review | Approved | |
| May 24, 2019 | Supplement 195Labeling · Standard review | Approved | |
| May 8, 2019 | Supplement 196Labeling · Standard review | Approved | |
| May 8, 2019 | Supplement 199Labeling · Standard review | Approved | |
| Apr 30, 2019 | Supplement 200Labeling · Standard review | Approved | |
| Jun 7, 2018 | Supplement 191Labeling · Standard review | Approved | |
| May 18, 2018 | Supplement 186Efficacy (new indication or use) · Standard review | Approved | |
| Jan 24, 2018 | Supplement 185Labeling · Standard review | Approved | |
| Jan 4, 2018 | Supplement 182Efficacy (new indication or use) · Standard review | Approved | |
| May 26, 2017 | Supplement 181Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2017 | Supplement 180Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 178Labeling · Standard review | Approved | |
| Mar 2, 2016 | Supplement 177Labeling · Standard review | Approved | |
| Jun 8, 2015 | Supplement 168Labeling · Standard review | Approved | |
| May 21, 2015 | Supplement 162REMS | Approved | |
| Apr 8, 2015 | Supplement 174Labeling · Standard review | Approved | |
| Feb 26, 2015 | Supplement 170Labeling · Standard review | Approved | |
| Dec 5, 2014 | Supplement 160Efficacy (new indication or use) · Priority review | Approved | |
| Jun 16, 2014 | Supplement 150Labeling · Standard review | Approved | |
| Jun 4, 2014 | Supplement 155Labeling · Standard review | Approved | |
| Aug 23, 2013 | Supplement 124Labeling · Standard review | Approved | |
| Aug 23, 2013 | Supplement 114Labeling · Standard review | Approved | |
| Jul 3, 2013 | Supplement 113Labeling · Standard review | Approved | |
| Jun 13, 2013 | Supplement 94Efficacy (new indication or use) · Priority review | Approved | |
| Feb 15, 2013 | Supplement 80Labeling · Standard review | Approved | |
| Sep 20, 2012 | Supplement 51Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2012 | Supplement 85Labeling · Standard review | Approved | |
| Jun 7, 2012 | Supplement 78Labeling · Standard review | Approved | |
| May 10, 2012 | Supplement 53Labeling · Standard review | Approved | |
| Apr 27, 2012 | Supplement 54Labeling · Standard review | Approved | |
| Sep 16, 2011 | Supplement 6 | Approved | |
| Sep 16, 2011 | Supplement 5 | Approved | |
| Jul 22, 2011 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 18, 2010 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jun 1, 2010 | Original applicationNew molecular entity · Standard 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
