FDA alerts: Potential risks associated with the compounding of remdesivir drug products
FDA alerts: Potential risks associated with the compounding of remdesivir drug products
On 22 October 2020, FDA approved a new drug application (NDA) for Veklury (remdesivir), a drug 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.
On 04 February 2021, FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products
The Veklury approval includes two presentations:
- remdesivir for injection, 100 milligrams (mg), a sterile, preservative-free lyophilized powder
- remdesivir injection, 100 mg/20 milliliters (mL) (5 mg/mL), a sterile, preservative-free solution
FDA alerts: Potential risks associated with the compounding of remdesivir drug products
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