Actavis receives approval from the European Commission for Xydalba (dalbavancin)

EMA

Actavis plc. today announced that the European Commission has granted Actavis' 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.

"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, healthcare professionals and hospitals greater flexibility in managing serious skin infections in both inpatient and outpatient sites of care. At Actavis, we are dedicated to helping bridge the gap in existing treatment options and are pleased to bring Xydalba to patients."

For more details, go to: http://www.actavis.com/news/news/thomson-reuters/actavis-receives-approval-from-the-european-commis

Michael Wonder

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Michael Wonder

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