CDER Approved 55 Novel Drugs in 2023

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FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

FDA’s Center for Drug Evaluation and Research (CDER) published its New Drug Therapy Approvals 2023 report on Jan. 16, 2024 highlighting new drugs approved in 2023. CDER approved 55 novel drugs during the year and expanded indications or patient populations for previously approved products.

The approved drugs treat a variety of diseases including COVID-19, respiratory syncytial virus (RSV), HIV, neurological conditions, anemia, weight management, type 2 diabetes, and endocrine disorders. Drugs were also approved that treat opioid addiction, three of which were over-the-counter opioid overdose reversal drugs.

More than half of the novel drugs approved were done so under the orphan drug designation program for rare diseases. Rare disease treatments include those for Friedreich’s ataxia, paroxysmal nocturnal hemoglobinuria, and activated phosphoinositide 3-kinase delta. Treatments were also approved for rare cancers such as mantle cell lymphoma and nasopharyngeal carcinoma.

There were five biosimilars approved in 2023 that included three for reference products that did not yet have a biosimilar. This brings the total of biosimilars approved by the agency to 45.


CDER also details in the report initiatives taken to create efficiencies in its review process. The center met or exceeded its Prescription Drug User Fee Act goal dates for89% of drug approvals. It also approved 84% of approvals on the “first cycle” and approved 35 of the 55 novel drugs before other countries. Thirty-six of the 55 drugs were approved using one of the agency’s expedited programs.

In an FDA Voices blog post, CDER Director Patrizia Cavazzoni stated, “Deciding whether to approve a drug is a collaborative, well-coordinated process. It often involves expertise from throughout our center and agency, as well as external parties. We take our regulatory decision-making seriously, because we know our drug approval actions affect the health and well-being of patients and consumers nationwide. I want to thank my colleagues for their dedication to reviewing and approving these drugs, which will benefit many people in years to come.”

Source: FDA