Treats unresectable or metastatic melanoma. BLA 125514, held by Merck Sharp Dohme. Pembrolizumab.
As of Nov 13, 2026, BLA 125514 (Keytruda), held by Merck Sharp Dohme, was first approved by FDA on Sep 4, 2014, with 127 approved supplements and 0 published complete response letters.
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2026 | Supplement 191Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2026 | Supplement 194Efficacy (new indication or use) · Priority review | Approved | |
| Jun 24, 2026 | Supplement 187Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2026 | Supplement 192Efficacy (new indication or use) · Priority review | Approved | |
| Feb 10, 2026 | Supplement 186Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2025 | Supplement 188Efficacy (new indication or use) · Priority review | Approved | |
| Jul 24, 2025 | Supplement 178Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2025 | Supplement 180Efficacy (new indication or use) · Priority review | Approved | |
| Jun 6, 2025 | Supplement 183Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2025 | Supplement 173Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2025 | Supplement 182Efficacy (new indication or use) · Priority review | Approved | |
| Apr 21, 2025 | Supplement 174Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2025 | Supplement 170Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2025 | Supplement 172Efficacy (new indication or use) · Priority review | Approved | |
| Dec 11, 2024 | Supplement 162Efficacy (new indication or use) · Standard review | Approved | |
| Sep 17, 2024 | Supplement 161Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2024 | Supplement 157Efficacy (new indication or use) · Standard review | Approved | |
| Jun 17, 2024 | Supplement 155Efficacy (new indication or use) · Priority review | Approved | |
| Jun 7, 2024 | Supplement 154Efficacy (new indication or use) · Standard review | Approved | |
| Jan 25, 2024 | Supplement 124Efficacy (new indication or use) · Standard review | Approved | |
| Jan 12, 2024 | Supplement 147Efficacy (new indication or use) · Priority review | Approved | |
| Dec 15, 2023 | Supplement 152Efficacy (new indication or use) · Priority review | Approved | |
| Dec 15, 2023 | Supplement 151Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2023 | Supplement 143Efficacy (new indication or use) · Standard review | Approved | |
| Nov 7, 2023 | Supplement 148Efficacy (new indication or use) · Standard review | Approved | |
| Oct 31, 2023 | Supplement 145Efficacy (new indication or use) · Standard review | Approved | |
| Oct 31, 2023 | Supplement 144Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2023 | Supplement 142Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2023 | Supplement 139Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2023 | Supplement 138Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2023 | Supplement 134Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2023 | Supplement 135Efficacy (new indication or use) · Standard review | Approved | |
| Apr 3, 2023 | Supplement 136Efficacy (new indication or use) · Priority review | Approved | |
| Mar 28, 2023 | Supplement 132Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2023 | Supplement 128Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2022 | Supplement 127Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2022 | Supplement 123Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2022 | Supplement 110Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2022 | Supplement 95Efficacy (new indication or use) · Priority review | Approved | None posted |
| Dec 17, 2021 | Supplement 120Efficacy (new indication or use) · Standard review | Approved | |
| Dec 3, 2021 | Supplement 112Efficacy (new indication or use) · Priority review | Approved | |
| Nov 17, 2021 | Supplement 113Efficacy (new indication or use) · Priority review | Approved | |
| Oct 13, 2021 | Supplement 121Efficacy (new indication or use) · Priority review | Approved | |
| Oct 13, 2021 | Supplement 122Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2021 | Supplement 117Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2021 | Supplement 118Efficacy (new indication or use) · Priority review | Approved | |
| Aug 10, 2021 | Supplement 102Efficacy (new indication or use) · Priority review | Approved | |
| Jul 26, 2021 | Supplement 89Efficacy (new indication or use) · Standard review | Approved | |
| Jul 26, 2021 | Supplement 114Efficacy (new indication or use) · Standard review | Approved | |
| Jul 21, 2021 | Supplement 105Efficacy (new indication or use) · Priority review | Approved | |
| Jul 1, 2021 | Supplement 100Efficacy (new indication or use) · Standard review | Approved | |
| May 5, 2021 | Supplement 97Efficacy (new indication or use) · Priority review | Approved | |
| Mar 22, 2021 | Supplement 96Efficacy (new indication or use) · Priority review | Approved | |
| Mar 16, 2021 | Supplement 91Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2021 | Supplement 93Efficacy (new indication or use) · Standard review | Approved | |
| Nov 13, 2020 | Supplement 88Efficacy (new indication or use) · Priority review | Approved | |
| Oct 14, 2020 | Supplement 85Efficacy (new indication or use) · Priority review | Approved | |
| Oct 2, 2020 | Supplement 70Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2020 | Supplement 84Efficacy (new indication or use) · Priority review | Approved | |
| Jun 24, 2020 | Supplement 68Efficacy (new indication or use) · Standard review | Approved | |
| Jun 24, 2020 | Supplement 92Efficacy (new indication or use) · Priority review | Approved | |
| Jun 16, 2020 | Supplement 71Efficacy (new indication or use) · Priority review | Approved | |
| Jun 16, 2020 | Supplement 90Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 59Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 60Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 62Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 64Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 69Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 76Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 77Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 78Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 79Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 80Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 81Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 82Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 83Efficacy (new indication or use) · Priority review | Approved | |
| Jan 8, 2020 | Supplement 66Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2019 | Supplement 65Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | Supplement 56Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | Supplement 55Efficacy (new indication or use) · Priority review | Approved | |
| Jun 17, 2019 | Supplement 53Efficacy (new indication or use) · Priority review | Approved | |
| Jun 10, 2019 | Supplement 52Efficacy (new indication or use) · Priority review | Approved | |
| Apr 19, 2019 | Supplement 54Efficacy (new indication or use) · Priority review | Approved | |
| Apr 11, 2019 | Supplement 47Efficacy (new indication or use) · Priority review | Approved | |
| Feb 15, 2019 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Dec 28, 2018 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2018 | Supplement 45Efficacy (new indication or use) · Priority review | Approved | |
| Nov 9, 2018 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Oct 30, 2018 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Aug 20, 2018 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Aug 16, 2018 | Supplement 46Efficacy (new indication or use) · Priority review | Approved | |
| Jun 19, 2018 | Supplement 43Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2018 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Jun 12, 2018 | Supplement 34Efficacy (new indication or use) · Priority review | Approved | |
| Sep 22, 2017 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| May 23, 2017 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2017 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2017 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| May 17, 2017 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2017 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Mar 14, 2017 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Oct 24, 2016 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Oct 24, 2016 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 2016 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2015 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2015 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Oct 2, 2015 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Sep 4, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Keytruda100MG/4ML (25MG/ML) · solution;intravenous | Pembrolizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2026 | Supplement 191Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2026 | Supplement 194Efficacy (new indication or use) · Priority review | Approved | |
| Jun 24, 2026 | Supplement 187Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2026 | Supplement 192Efficacy (new indication or use) · Priority review | Approved | |
| May 12, 2026 | Supplement 190Labeling · Standard review | Approved | |
| Apr 6, 2026 | Supplement 195Labeling · Standard review | Approved | |
| Feb 10, 2026 | Supplement 186Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2025 | Supplement 188Efficacy (new indication or use) · Priority review | Approved | |
| Jul 24, 2025 | Supplement 178Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2025 | Supplement 180Efficacy (new indication or use) · Priority review | Approved | |
| Jun 6, 2025 | Supplement 183Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2025 | Supplement 173Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2025 | Supplement 182Efficacy (new indication or use) · Priority review | Approved | |
| Apr 21, 2025 | Supplement 174Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2025 | Supplement 170Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2025 | Supplement 172Efficacy (new indication or use) · Priority review | Approved | |
| Dec 11, 2024 | Supplement 162Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2024 | Supplement 164Labeling · Standard review | Approved | |
| Sep 17, 2024 | Supplement 161Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2024 | Supplement 157Efficacy (new indication or use) · Standard review | Approved | |
| Jul 31, 2024 | Supplement 158Labeling · Standard review | Approved | |
| Jun 17, 2024 | Supplement 155Efficacy (new indication or use) · Priority review | Approved | |
| Jun 7, 2024 | Supplement 154Efficacy (new indication or use) · Standard review | Approved | |
| Mar 11, 2024 | Supplement 160Labeling · Standard review | Approved | |
| Jan 25, 2024 | Supplement 124Efficacy (new indication or use) · Standard review | Approved | |
| Jan 12, 2024 | Supplement 147Efficacy (new indication or use) · Priority review | Approved | |
| Dec 15, 2023 | Supplement 152Efficacy (new indication or use) · Priority review | Approved | |
| Dec 15, 2023 | Supplement 151Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2023 | Supplement 143Efficacy (new indication or use) · Standard review | Approved | |
| Nov 7, 2023 | Supplement 148Efficacy (new indication or use) · Standard review | Approved | |
| Oct 31, 2023 | Supplement 145Efficacy (new indication or use) · Standard review | Approved | |
| Oct 31, 2023 | Supplement 144Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2023 | Supplement 142Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2023 | Supplement 139Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2023 | Supplement 138Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2023 | Supplement 134Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2023 | Supplement 135Efficacy (new indication or use) · Standard review | Approved | |
| Apr 3, 2023 | Supplement 136Efficacy (new indication or use) · Priority review | Approved | |
| Mar 28, 2023 | Supplement 132Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2023 | Supplement 128Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2022 | Supplement 127Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 2022 | Supplement 133Labeling · Standard review | Approved | |
| Jun 21, 2022 | Supplement 131Labeling · Standard review | Approved | |
| May 20, 2022 | Supplement 123Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2022 | Supplement 110Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2022 | Supplement 95Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 4, 2022 | Supplement 125Labeling · Standard review | Approved | |
| Dec 17, 2021 | Supplement 120Efficacy (new indication or use) · Standard review | Approved | |
| Dec 3, 2021 | Supplement 112Efficacy (new indication or use) · Priority review | Approved | |
| Nov 17, 2021 | Supplement 113Efficacy (new indication or use) · Priority review | Approved | |
| Oct 13, 2021 | Supplement 121Efficacy (new indication or use) · Priority review | Approved | |
| Oct 13, 2021 | Supplement 122Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2021 | Supplement 117Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2021 | Supplement 118Efficacy (new indication or use) · Priority review | Approved | |
| Aug 10, 2021 | Supplement 102Efficacy (new indication or use) · Priority review | Approved | |
| Aug 3, 2021 | Supplement 104Labeling · Standard review | Approved | |
| Jul 26, 2021 | Supplement 89Efficacy (new indication or use) · Standard review | Approved | |
| Jul 26, 2021 | Supplement 114Efficacy (new indication or use) · Standard review | Approved | |
| Jul 21, 2021 | Supplement 105Efficacy (new indication or use) · Priority review | Approved | |
| Jul 1, 2021 | Supplement 100Efficacy (new indication or use) · Standard review | Approved | |
| Jun 28, 2021 | Supplement 108Labeling · Standard review | Approved | |
| May 5, 2021 | Supplement 97Efficacy (new indication or use) · Priority review | Approved | |
| Mar 30, 2021 | Supplement 106Labeling · Standard review | Approved | |
| Mar 22, 2021 | Supplement 96Efficacy (new indication or use) · Priority review | Approved | |
| Mar 16, 2021 | Supplement 91Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2021 | Supplement 93Efficacy (new indication or use) · Standard review | Approved | |
| Feb 10, 2021 | Supplement 98Manufacturing | Approved | |
| Nov 13, 2020 | Supplement 88Efficacy (new indication or use) · Priority review | Approved | |
| Nov 10, 2020 | Supplement 48Labeling · Standard review | Approved | |
| Oct 14, 2020 | Supplement 85Efficacy (new indication or use) · Priority review | Approved | |
| Oct 2, 2020 | Supplement 70Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2020 | Supplement 84Efficacy (new indication or use) · Priority review | Approved | |
| Jun 24, 2020 | Supplement 68Efficacy (new indication or use) · Standard review | Approved | |
| Jun 24, 2020 | Supplement 92Efficacy (new indication or use) · Priority review | Approved | |
| Jun 16, 2020 | Supplement 71Efficacy (new indication or use) · Priority review | Approved | |
| Jun 16, 2020 | Supplement 90Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 59Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 60Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 62Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 64Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 69Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2020 | Supplement 76Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 77Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 78Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 79Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 80Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 81Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 82Efficacy (new indication or use) · Priority review | Approved | |
| Apr 28, 2020 | Supplement 83Efficacy (new indication or use) · Priority review | Approved | |
| Jan 9, 2020 | Supplement 67Labeling · Standard review | Approved | |
| Jan 8, 2020 | Supplement 66Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2019 | Supplement 65Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | Supplement 56Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | Supplement 55Efficacy (new indication or use) · Priority review | Approved | |
| Jun 17, 2019 | Supplement 53Efficacy (new indication or use) · Priority review | Approved | |
| Jun 10, 2019 | Supplement 52Efficacy (new indication or use) · Priority review | Approved | |
| Apr 19, 2019 | Supplement 54Efficacy (new indication or use) · Priority review | Approved | |
| Apr 11, 2019 | Supplement 47Efficacy (new indication or use) · Priority review | Approved | |
| Feb 15, 2019 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Dec 28, 2018 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2018 | Supplement 45Efficacy (new indication or use) · Priority review | Approved | |
| Nov 9, 2018 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Oct 30, 2018 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Aug 20, 2018 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Aug 16, 2018 | Supplement 46Efficacy (new indication or use) · Priority review | Approved | |
| Jun 19, 2018 | Supplement 43Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2018 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Jun 12, 2018 | Supplement 34Efficacy (new indication or use) · Priority review | Approved | |
| Nov 29, 2017 | Supplement 31Labeling · Standard review | Approved | |
| Sep 22, 2017 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Jul 27, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Jul 27, 2017 | Supplement 19Labeling · Standard review | Approved | |
| May 23, 2017 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2017 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| May 18, 2017 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| May 17, 2017 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2017 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Mar 14, 2017 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Oct 24, 2016 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Oct 24, 2016 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 2016 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2015 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2015 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Oct 2, 2015 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jun 19, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Sep 4, 2014 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
