Infectious Disease

FDA Approves Dalvance for Pediatric ABSSSI Treatment

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According to a press release, the FDA has approved AbbVie’s Dalvance (dalbavancin) for the treatment of acute bacterial infections of the skin and texture in pediatric patients from birth.

Dalvance is the first single-dose option to be given as a 30-minute intravenous infusion to treat ABSSSI caused by identified susceptible Gram-positive bacteria in pediatric patients, including infections caused by MRSA, the company said.

The approval was based on the results of a multicenter, open-label, actively controlled clinical trial evaluating Dalvance in pediatric patients from birth to under 18 years of age with ABSSSI and three pharmacokinetic studies.

“Serious infections in children can be difficult to treat and the effects of ABSSSI in children are significant, as these infections often require IV antibiotics, leading to hospitalization,” said Margaret Burroughs, AbbVie Medical Director, Infectious Diseases. “This single-dose pediatric approval of Dalvance is useful in the treatment of children and infants with ABSSSI.”

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