Every month, Outbound Pharma compiles a list of the US FDA new drug approvals. The list includes New Drug Applications (NDA), Biologics License Applications (BLA) and Abbreviated New Drug Application (ANDA) approvals.
FDA New Drug Approvals - April 2024
In April 2024, the US FDA approved a total of 24 NDA/BLAs and 43 ANDAs.
Application type | Number of approvals | Approved by |
NDA/BLA | 20/4 | CDER |
ANDA | 68 | CDER |
BLA | 0 | CBER |
Compared to the same month last year, the FDA approved 14 more NDA/BLAs and 4 more ANDAs.
NDA/BLA Approvals
As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
In April 2024, the following drugs were approved for the first time:
BLA Approvals (by CBER)
The Center for Biologics Evaluation and Research (CBER) is one of the key centers within the Food and Drug Administration (FDA) that regulates Biological products.
In April 2024, no new BLAs were approved.
Sources: The information provided in this blog article is sourced from the official website of the United States Food and Drug Administration (FDA). https://www.fda.gov/.
What is included: This report includes all BLAs/NDAs/ANDAs approved by the Center for Drug Evaluation and Research (CDER), as well as Biological License Application approvals regulated by the Center for Biologics Evaluation and Research (CBER) (e.g. vaccines, in vivo diagnostic allergenic products, in vivo diagnostic tests for DTH, human blood and blood-derived products, immunoglobulin products, cellular and gene therapy products). What is not included: This report does not include Supplemental Approvals to NDAs and BLAs or ANDA supplement approvals or tentative ANDA approvals. It also does not include Biological Device Applications for devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.
Disclaimer: While every effort has been made to ensure the accuracy and reliability of the information presented herein, it is important to acknowledge that errors or inaccuracies may inadvertently occur. Readers are advised to independently verify any information presented in this article and consult with qualified professionals or official sources for specific guidance or advice related to their individual circumstances. The author and publisher of this article disclaim any liability for any loss or damage resulting from reliance on the information provided herein. Furthermore, please be aware that the content of this article is intended for informational purposes only and should not be construed as medical, legal, or professional advice. Readers are encouraged to seek appropriate professional assistance or consultation as needed.
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