Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues –

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By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide variety of safe and effective new drug therapies in 2021 despite challenges brought on by the ongoing COVID-19 pandemic. These new approvals, spanning a wide range of diseases and conditions, aim to help many patients live better and potentially longer lives. 
In 2021, we approved 50 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also approved drugs in new capacities, such as for new uses and patient populations. 
The 2021 approvals target diseases and conditions such as:
Patients with rare diseases are often in critical need of new therapies, as these individuals often have few or no existing treatment options. In encouraging news, last year more than half (26 of 50, or 52%) of our novel drug approvals were for rare diseases, including:
Our 2021 approvals demonstrate efficiencies in our review process, such as:
CDER approved the first two interchangeable biosimilar products in 2021, which are biological products that may be substituted without the intervention of a prescriber. More biosimilar and interchangeable biosimilar products on the market means greater competition that may lead to increased access to therapies and lower costs for patients.
More details about CDER’s drug approvals for 2021 — including specific examples of notable approvals — are available in our annual New Drug Therapy Approvals report. I want to also mention that the FDA’s Center for Biologics Evaluation and Research (CBER) approves important therapies as well. In 2021, CBER approved the first COVID-19 vaccine, an important tool in our continued fight against the pandemic. For more information about CBER actions, visit CBER’s web page for 2021 Biological Approvals.  
I enjoy working with so many talented individuals in CDER who are determined to bring new drug therapies to patients as quickly as possible, while also ensuring that every approval is based on our consistently high standards for science, safety, and effectiveness. As 2022 begins, our center looks forward to continuing this important work in the name of public health.
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