VANCOUVER, Aug. 9, 2016 - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that XYDALBA™ (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). This single dosing regimen is in addition to the initially approved dosing regimen of 1000 mg (two 500mg vials) followed one week later by 500 mg (a single 500mg 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 (ABSSSIs) in adults and by the U.S. Food and Drug Administration (FDA) in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.
Read more: http://www.cardiome.com/investors/news/archives/2016/cardiome-announces-xydalba%E2%84%A2-single-dose-infusion-approval-european-medi