Washington – The US 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.
Therapies For Many Types of Diseases and Conditions
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.
In the opioid overdose space, weapproved drugs to treat opioid use, misuse, and abuse. Specifically, we approved three opioid overdose reversal drugs as over-the-counter products. We also approved new dosage forms of drugs that reverse opioid overdose and treat opioid use disorder, giving patients more treatment options. With respect to lung diseases, our approval actions included therapies for asthma attacks and cystic fibrosis. For gastrointestinal conditions, we approved drugs for inflammatory bowel disease and pediatric functional constipation.
In oncology, approvals included treatments for colorectal, prostate, lung, and low-grade gliomas (tumors that start in the brain). In the area of women’s health, CDER approved treatments for postpartum depression, hot flashes due to menopause, and over-the-counter oral contraception.