SPECIAL BULLETIN COVID-19 #222: FDA Approves Remdesivir (Veklury) for Qualifying Pediatric Patients
Revisions to previous scope of authorization

Revisions to previous scope of authorization

On Jan. 21, 2022, the FDA approved authorization of Remdesivir (Veklury) for the treatment of COVID-19 in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients younger than age 12 weighing at least 3.5 kg, with positive results of direct SARS-CoV-2 viral testing, who are hospitalized or not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. This authorization is a supplemental application with revisions to the scope of authorization previously authorizing Remdesivir (Veklury).

As of Jan. 21, 2022, NC Medicaid and Health Choice will cover Veklury for pediatric patients younger than 12 years of age who meet criteria for treatment. Please see NC Medicaid Special Bulletin COVID-19 #210 for details on claims processing. 

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