|Trade Name||DEFLUX INJECTABLE GEL|
|Classification Name||agent, bulking, injectable for gastro-urology use|
|Applicant||SALIX PHARMACEUTICALS, INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the introduction of in-house produced water for injection (wfi), as well as clearance for the use of pharmaceutical grade naoh and hcl, rather than the grade currently used by the firm.