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Allergan announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA), to update the label for Dalvance (dalbavancin) for injection.
It is now approved for use as a single dose administered as a 30 minute intravenous (IV) infusion for the treatment of acute bacterial skin and skin structure infections (ABSSSI), caused by designated Gram-positive bacteria in adults. This includes infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
RELATED: Single-Dose Antibiotic for ABSSSI Accepted for Review
The FDA approval was based on data from DUR001-303, a Phase 3 study that compared a single 1500mg dose of Dalvance with the 2-dose regimen of 1000mg, followed by 500mg one week later. The results showed that the 1500mg single dose met its primary endpoint of non-inferiority to the 2-dose regimen at 48–72 hours after treatment initiation, as determined by a decrease of ≥20% in lesion area relative to the baseline measurement (81.4% vs. 84.2%, respectively, difference -2.9, 95% CI: -8.5, 2.8).
Dalvance, a 2nd-generation, semi-synthetic lipoglycopeptide antibiotic, is the first 30-minute, single-dose option for ABSSSI. It was initially approved in May 2014 for the treatment of adults with ABSSSI.
For more information call (800) 433-8871 or visit Dalvance.com.
