Efficacy Supplement Approvals
1998-2014 reports are in the FDA Archive
Efficacy Supplement Reports
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2023
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2022
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2021
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2020
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2019
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2018
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2017
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2016
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2015
Summary Level Review Report
- Report of Summary Level Review Under Section 3031 of 21st Century Cures - 2017 to 2023 (PDF - 146KB)