DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients
NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE(dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.
- NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE(dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.
- "This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."
- ABSSSI are bacterial infections of skin and associated tissues primarily caused by Gram-positive pathogens, including Staphylococcus aureus and Streptococcus pyogenes.
- Results from the clinical trial in pediatric patients show that the safety findings of DALVANCE in pediatric patients were similar to those observed in adults.