The drug, sold under the brand name Veklury, has been used under emergency use authorization. It is the first drug to be approved for treating Covid-19.
"In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization," the company said in 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."
Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a US study found the infused drug shortened recovery time for some patients by about a third.
The FDA uses data submitted by a drug's maker when it's considering approval. Gilead submitted a study published in the New England Journal of Medicine that showed the drug shortened the course of illness from an average of 15 days to about 11 days in hospitalized patients.
The FDA also considered two other studies. One showed a slight benefit of the drug and another showed the drug did not make much difference.
"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic," FDA Commissioner Dr. Stephen Hahn said in a statement.
"As part of the FDA's Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks."
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