Salix Receives FDA CDRH Approval for Additional Injection Techniques for Deflux

Salix Pharmaceuticals

today announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux® premarket approval (PMA) supplement, which requested approval of labeling changes to add two additional techniques for injection, a single intra-ureteric injection (HIT procedure) and a double (proximal and distal) intra-ureteric injection (Double-HIT procedure). “Deflux® has always been an effective, minimally invasive option for children suffering from vesicoureteral reflux grades II-IV. This approval and update to the Deflux® labeling provides pediatric urologists even more confidence to offer Deflux to families,” said Carolyn Logan, President and CEO of Salix.