Salix Receives FDA CDRH Approval for Additional Injection Techniques for Deflux

Salix Pharmaceuticals (NASDAQ: SLXP) 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. See full press release