9 October 2015 - Allergan plc announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Allergan's supplemental New Drug Application (sNDA). This filing will expand the label to include single-dose administration of Dalvance (dalbavancin hydrochloride) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

"With the FDA's acceptance of this supplemental application, Allergan is one step closer to providing a single-dose option of Dalvance which may provide more flexibility to manage serious skin infections in an outpatient setting," said David Nicholson, Executive Vice President and President Global Brands Research and Development, Allergan. "Dalvance is an important part of Allergan's anti-infective portfolio focused on addressing infections in multiple clinical settings to help improve outcomes for patients and the healthcare system."

The application was based on results from a Phase 3 study DUR001-303, which compared a single 1,500 mg dose of Dalvance with the two-dose regimen of 1,000 mg followed one week later by 500 mg. Data demonstrated the 1,500 mg single dose of Dalvance achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48 to 72 hours after initiation of therapy, as determined by a decrease of > 20% in lesion area relative to the baseline measurement (81.4% vs. 84.2% for the single dose vs. the two dose regimen, respectively; difference -2.9; 95% CI: -8.5, 2.8).

For more details, go to: http://www.allergan.com/news/news/thomson-reuters/fda-accepts-supplemental-new-drug-application-snda