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.
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