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News From the Food and Drug Administration
February 21, 2017

Novel Drugs Passed Muster in 2016

Author Affiliations
 

Copyright 2017 American Medical Association. All Rights Reserved.

JAMA. 2017;317(7):688. doi:10.1001/jama.2017.0312

During 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel drugs—new molecular entities or therapeutic biologics—that serve unmet medical needs or significantly advance patient care and public health.

Eight of the novel drugs were first-in-class products, which typically have different mechanisms of action than existing treatments. Among them were defibrotide sodium, a medication for children and adults who develop hepatic veno-occlusive disease with renal or pulmonary complications following hematopoietic stem cell transplant, and daclizumab for adults with relapsing multiple sclerosis.

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