WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration approved AbbVie's (ABBV) Dalvance or dalbavancin for the treatment of acute bacterial skin and skin structure infections or ABSSSI in pediatric patients from birth.
Dalvance is the first single-dose option administered as a 30-minute intravenous (IV) infusion for the treatment of ABSSSI caused by designated susceptible Gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
ABSSSI are bacterial infections of skin and associated tissues primarily caused by Gram-positive pathogens, including Staphylococcus aureus and Streptococcus pyogenes.
This approval was based on results from a multicenter, open-label, actively controlled clinical trial evaluating DALVANCE in pediatric patients from birth to less than 18 years of age with ABSSSI and 3 pharmacokinetic studies.
The approved recommended dosage regimen of DALVANCE in pediatric 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 pediatric patient.
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