Research & Development
AbbVie's DALVANCE receives US FDA approval
26 July 2021 -

US-based AbbVie (NYSE: ABBV) announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for its DALVANCE (dalbavancin) to treat acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients from birth.

The product is the first single-dose option administered as a 30-minute intravenous (IV) infusion to treat ABSSSI caused by designated susceptible Gram-positive bacteria in paediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus.

DALVANCE received approval based on results from a multicentre, open-label, actively controlled clinical trial in paediatric patients from birth to less than 18 years of age with ABSSSI and three pharmacokinetic studies. The approved recommended dosage regimen for the product in paediatric patients with a creatinine clearance of 30 mL/min/1.73m2 and above is a single-dose regimen based on the age and weight of the paediatric patient.

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