Veklury FDA Approval History
Last updated by Judith Stewart, BPharm on July 18, 2023.
FDA Approved: Yes (First approved October 22, 2020)
Brand name: Veklury
Generic name: remdesivir
Dosage form: Injection
Company: Gilead Sciences, Inc.
Treatment for: COVID-19
Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19.
- Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are:
- hospitalized, or
- not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. - Veklury contains remdesivir, a nucleotide analog antiviral which works to inhibit viral replication by targeting SARS-CoV-2 viral RNA polymerase.
- Veklury is administered by intravenous infusion over 30 to 120 minutes.
- Warnings and precautions associated with Veklury include hypersensitivity including infusion-related and anaphylactic reactions; increased risk of transaminase elevations; and risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate.
- Common adverse reactions include nausea and increased liver enzymes (ALT and AST).
Development timeline for Veklury
Further information
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