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FDA Approved the First Drug to Treat COVID-19 for Adults and Pediatric Patients
FDA NEWS RELEASE
WASHINGTON, DC – On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. The FDA revised the Emergency Use Authorization (EUA) for Veklury to remove those uses that are now approved under Gilead’s New Drug Application (NDA). The EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.
The FDA consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing, including for products to diagnose, cure, mitigate, treat or prevent COVID-19 and for other critically needed products to treat symptoms of COVID-19 or to provide supportive care to those with COVID-19. The FDA is committed towards getting medical products to market quickly and to helping ensure that these products are safe, effective and high quality. Manufacturers, applicants and sponsors, including those working under U.S. government contracts, can use these resources to find information on the applicable laws and regulations that govern drug development and manufacturing to protect the public health, including during the COVID-19 outbreak.
The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary which provides a quick look at facts, figures and highlights of the agency’s response efforts.
As of today, 283 tests are authorized by FDA under EUAs; these include 221 molecular tests, 56 antibody tests, and 6 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.