This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the Center for Drug Evaluation and Research (CDER). The listed NMEs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under a Biologics License Application (BLA). The product information, indications, and regulatory characteristics described in the compilation reflect the state of each application at the time of original marketing approval.
- Compilation of CDER NME and New Biologic Approvals 1985-2019
- Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals - Data Dictionary (PDF - 213KB)
DISCLAIMER: This dataset provides publicly available data on CDER NME and new biologic approvals (1985-2019) in a single-file, analyzable and user-friendly format. This dataset is for research purposes only and some fields have been simplified for ease of presentation. This dataset is a high-level compilation of existing, publicly available data from FDA’s internal databases and document records, and to the best of our knowledge, reflects the state of each application at the time of initial regulatory approval. For additional or more detailed information about an application (e.g., FDA-approved conditions of use, approval letters), consider reviewing information available on Drugs@FDA or in the Orange Book. The agency aims to provide accurate information in this dataset and on this website. If you believe there is a factual error in the information presented, you can report this to CDER.NMENewBiologicApprovals@fda.hhs.gov.