AbbVie Inc. received U.S. Food and Drug Administration approval for its treatment of acute bacterial skin and skin structure infections in children and infants, the company said Friday.
The Dalvance drug is administered intravenously in a single dose. In clinical trials, the treatment was found to reduce lesion size and didn't require rescue antibacterial therapy for children 3 months and older, the company said. The treatment's safety findings in pediatric patients were also similar to those seen in adults, it said.
Such skin infections are caused by Gram-positive pathogens, such as Staphylococcus aureus and Streptococcus pyogenes, and they can be serious and life-threatening, AbbVie said.
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