Chennai: The US Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of Covid-19 requiring hospitalization.
According to a statement, Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for Covid-19 to receive FDA approval, it added.
This approval does not include the entire population that had been authorised to use Veklury under an Emergency Use Authorization (EUA) originally issued on 1 May, 2020.
The FDA granted approval and reissued the revised EUA to Gilead Sciences Inc. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drugās intended use(s).