9 August 2016 - Cardiome Pharma Corporation has announced that Xydalba (dalbavancin hydrochloride) has been approved by the EMA for administration as a single, 30 minute, 1,500 mg infusion (three 500 mg vials).

This single dosing regimen is in addition to the initially approved dosing regimen of 1000 mg (two 500 mg vials) followed one week later by 500 mg (a single 500 mg vial).

"We are pleased that the EMA has approved the single dose administration of Xydalba," said Kiran Bhirangi, M.D., Cardiome's Head of Medical Affairs. "This approval aligns the dosing regimen with the U.S. label, but more importantly, it could enhance the convenience of antibiotic administration for both healthcare providers and their patients. We anticipate that Xydalba will be available to physicians within some of the major territories under license by Cardiome during the fourth quarter of 2016."

Xydalba was approved by the EMA in February 2015 as a treatment for acute bacterial skin and skin structure infections in adults and by the U.S. FDA in May 2014 for the treatment of adult patients with acute bacteroial skin and skin structure infection caused by susceptible Gram-positive bacteria, including MRSA.

In May 2016, Cardiome announced the signing of an exclusive license agreement with an affiliate of Allergan to commercialize Xydalba in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada. Dalvance (dalbavancin hydrochloride) is marketed in the United States by Allergan.

Read Cardiome Pharma Corporation press release