European Commission approves Actavis' Xydalba

The European Commission has granted Ireland-headquartered Actavis' (NYSE: ACT) subsidiary Durata Therapeutics International 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 1,000mg followed one week later by 500mg, each administered over 30 minutes.

"We are excited that Xydalba has received regulatory approval throughout Europe," said David Nicholson, Executive Vice President, Global Brands Research and Development, Actavis. "The unique dosage regimen of Xydalba provides a new treatment approach that gives patients, health care professionals and hospitals greater flexibility in managing serious skin infections in both inpatient and outpatient sites of care."