FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives. 

In 2023, CDER approved 55 novel drugs, as detailed in our annual New Drug Therapy Approvals report. The active ingredient(s) in a novel drug have not been previously FDA-approved. We also took other important actions, such as expanding the indications or patient populations of some previously approved therapies. In addition, we approved new dosage forms or drug formulations and made some prescription drugs available over-the-counter.

Our 2023 actions target a wide range of disease areas. For example, we approved treatments for infectious diseases, including COVID-19, respiratory syncytial virus (RSV), and HIV. CDER also approved therapies for neurological conditions, such as amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and migraine. Moreover, we took approval actions for drugs targeting type 2 diabetes in children, different types of anemia, and chronic weight management, among other heart, blood, kidney, and endocrine disorders.

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