Salix Pharma Reports Approval Of Addl. Injection Techniques For Deflux

(RTTNews) - Salix Pharmaceuticals, Ltd. (SLXP) said that The Center for Devices and Radiological Health or CDRH of the Food and Drug Administration or FDA has approved the Deflux premarket approval or 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 intra-ureteric injection (Double-HIT procedure).

President and Chief Executive of Salix said, "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."

The company said several techniques were described for the endoscopic treatment of vesicoureteral reflux, including a subureteric injection (STING procedure), the HIT procedure and the Double-HIT procedure. The Double-HIT procedure is a refinement of the original STING and HIT procedures and has been reported to result in greater clinical success rates.

DEFLUX is indicated for the treatment of children with vesicoureteral reflux grades II-IV.