Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product these products frequently provide important new therapies for patients. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.Ĭertain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review.This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2018 by the Center for Biologics Evaluation and Research. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2018. Some of these products are innovative new products that never have been used in clinical practice.For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.Įach year, CDER approves a wide range of new drugs and biological products: The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.
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