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January 21, 2022 – The U.S. FDA has expanded approval and emergency use authorization (EUA) for Gilead's Veklury® (remdesivir) to treat COVID-19 in certain high-risk individuals. The updates allow treatment of certain high-risk patients outside of a hospital setting. Veklury was previously limited to use in patients requiring hospitalization.
- The expanded approval indicates the drug for use in non-hospitalized patients at least 12 years of age (weighing at least 40kg, or about 88 pounds) who have positive results of direct SARS-CoV-2 viral testing, have mild-to-moderate COVID-19, and are at high risk of progression to severe COVID-19, including hospitalization or death.
- The updated EUA authorizes Veklury for treatment of non-hospitalized pediatric patients who have positive results of direct SARS-CoV-2 viral testing, have mild-to-moderate COVID-19, are at high risk of progression to severe COVID-19, and weigh 3.5kg (about eight pounds) to less than 40kg or are under 12 years of age and weigh at least 3.5kg.
- Under the expanded approval and EUA, the recommended total duration of treatment for non- hospitalized patients is three days. Recommended dosing is based on the indication and the patient's age and weight. Veklury is administered via intravenous infusion.