FDA Approved Nearly 50 Percent More Drugs in 2023 Than in 2022

Only 2018 featured a higher number of drug approvals.

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Over 50 new drugs or treatments were approved in 2023 by the U.S. Food and Drug Administration (FDA), representing over a 45 percent increase over 2022. This marks the highest number of approvals by the agency since the COVID-19 pandemic.

The FDA approved 37 drugs in 2022, a drastic reduction from 51 approvals in 2021, 53 in 2020, 48 in 2019, and a peak of 59 in 2018. The last time the agency hit such a low was in 2016, when it approved just 22 new drugs.

“Innovative drugs often mean new treatment options for patients and advances in health care for the American public,” the FDA states on its website.

2023’s 55 new drugs exclude any vaccines, allergenic products, blood or blood products, plasma derivatives, or cellular and gene therapy products approved by the Center for Biologics Evaluation and Research (CBER), which operates within the FDA to approve drugs derived from biological sources.

For a new drug to receive approval under the federal Food, Drug, and Cosmetic Act, its manufacturer must show substantial evidence of its effectiveness and safety. The FDA conducts a risk-benefit analysis based on rigorous scientific standards to ensure the medication’s benefits outweigh any potential risks, according to the FDA.

Approval Highlights

Some of the headline drugs approved in 2023 include lecanemab-irmb (Leqembi), zavegepant (Zavzpret), nirsevimab-alip (Beyfortus), nirmatrelvir (Paxlovid), and tirzepatide (Zepbound).

Lequembi, a drug created by Eisai and Biogen to treat Alzheimer’s disease, was granted accelerated approval in January 2023 and full approval in July 2023.

Pfizer’s Zavzpret was approved in March 2023 to treat migraines in adults. Prescribed as a nasal spray, the drug is touted as an alternative for people who need pain relief from migraines but cannot tolerate traditional oral medications due to nausea or vomiting.

Beyfortus, approved in July 2023, is prescribed for babies and toddlers to prevent respiratory syncytial virus (RSV). Approximately 1 percent to 3 percent of children under 12 years old in the United States are hospitalized each year with RSV, according to the American Academy of Pediatrics.

The approval “addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system,” Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release when the drug was approved.

Some have hailed Paxlovid as a game-changing drug for treating COVID-19 symptoms; the oral antiviral medication was approved in May for use by adults as well as children ages 12 through 18 to treat mild-to-moderate COVID-19 symptoms. Others have questioned its usefulness as more recent trials have produced declining efficacy rates.

“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release when Paxlovid was approved.

Zepbound: Another Weight-Management Drug

Eli Lilly’s Zepbound was approved in November to help adults manage chronic overweight issues and obesity. While tirzepatide is not novel (Mounjaro also uses it, among others), the November approval was the first time the FDA OK’d the drug’s use for chronic weight management.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release when the drug was approved. “In light of increasing rates of both obesity and overweight in the United States, [the] approval addresses an unmet medical need.”

According to the FDA, about 70 percent of American adults are obese or overweight, and many also have a weight-related condition.