10 January 2018 - In 2017, FDA’s Center for Drug Evaluation and Research approved many new drugs never before marketed in the United States, known as “novel” drugs, to help improve people’s health.

Novel drugs often represent innovative therapies for advancing patient care. 2017 was no exception. We approved new treatments for patients with rare diseases such as Batten disease, Chagas disease, and haemophilia A with inhibitors. We also approved new cancer therapies, new antibiotics, and new therapies for patients with multiple sclerosis, Parkinson’s disease, tardive dyskinesia, Duchenne muscular dystrophy, and amyotrophic lateral sclerosis (often called Lou Gehrig’s disease), among many others.

For the past six years, we have summarised our novel drug approvals in an annual report. This year, we expanded the report beyond novel approvals to show a wide range of other drug therapy approvals that help improve health. For example, we approved many new uses for drugs already on the market, extending their benefits and expanding their reach into new populations, such as children. We have also approved new dosage forms for drugs already available. These are the kinds of actions, separate from approving a novel drug, that can also provide important medical value.

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