logo
  

FDA Approves AbbVie's Dalvance To Treat Acute Bacterial Skin & Skin Structure Infections In Children

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Salt Lake City, Utah-based Huish Outdoors is recalling Oceanic Adult Dry Top Snorkels sold exclusively at Costco citing risk for drowning, U.S. Consumer Product Safety Commission said. The recall involves about 76,000 units of Oceanic Adult Dry Top Snorkels. The recall was initiated after Oceanic received 13 reports of the snorkels leaking. Boeing expects Europe's commercial aviation fleet to need 8,705 new airplanes through 2040 to cater to the growing leisure travel market in the region and fleet replacements with more fuel-efficient models, according to the Boeing's 2021 Commercial Market Outlook (CMO), an annual forecast of long-term demand for commercial airplanes and services. The U.S. Food and Drug Administration authorized marketing of a software developed by Paige.AI, a provider of AI-based digital diagnostics, which could help pathologists to identify prostate cancer. The software, called Paige Prostate, is the first and only artificial intelligence or AI-based pathology product to receive FDA approval for in vitro diagnostic or IVD use in detecting cancer...
Follow RTT