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  5. Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
  1. Drug Approvals and Databases

Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals

This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2023 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.

Key Concepts

  • For users that wish to further research one or more products listed in the dataset, please refer to FDA’s Orange Book, Purple Book, and Drugs@FDA for more information on NDA/BLA Approvals.
  • During the drug review process, FDA will assign a classification code to new applications based on the characteristics of the product. For the purposes of this dataset, only products with a Type 1 or Type 1/4 are considered NMEs. For a full list of FDA’s classification codes and their descriptions, please refer to the CDER Classification MAPP.
  • The Compilation dataset contains Approved NMEs reviewed under CDER only. This dataset does not include blood products, vaccines, gene therapies, etc. that are normally reviewed under Center for Biologics Evaluation and Research (CBER). Those approvals can be found at Biological Approvals by Year.
  • Updates to the dataset will be made annually after the new approvals are confirmed with the system of record.
  • The Compilation is not intended to replace existing public reports or resources, but to enhance and expand the ability to find trends throughout the “modern” review process.
  • A number of products listed in the dataset have been administratively changed from NDAs to BLAs. They are identified as such in the comments field. The reason for this change is cited below:

Beginning on March 23, 2020, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act shall be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act. The 10-year transition period between the law’s enactment on March 23, 2010, and March 23, 2020, provided sponsors of biological products that are affected by the statutory transition with time to prepare for the transition, and allowed biological products submitted under section 505 of the FD&C Act time to be approved before March 23, 2020. “Deemed to be a License” Provision of the BPCI Act

Compilation Dataset Links

DISCLAIMER: This dataset provides publicly available data on CDER NME and new biologic approvals (1985-2023) 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. 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.

Resource

Novel Drug Approvals at FDA

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