Actavis Gets Approval From The European Commission For XYDALBA - Quick Facts

(RTTNews) - Actavis plc (ACT) announced that the European Commission has granted its subsidiary Durata Therapeutics International B.V., marketing authorization for XYDALBA (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

XYDALBA is the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.

The new treatment's unique dosage regimen offers a new approach to the treatment of ABSSSI.

The European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 18 December 2014 and is applicable to all 28 Member States and the three European Economic Area countries not Member States of the European Union.