|Trade Name||UVAR XTS PHOTOPHERESIS SYSTEM|
|Classification Name||system, photopheresis, extracorporeal|
|Generic Name||system, photopheresis, extracorporeal|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change (inclusion of an additional warning) to address the potential for the development of hypovolemia and hypotension during photopheresis treatments in patients with elevated triglyceride levels (hyperlipidemia), such as patients receiving certain cutaneous t-cell lymphoma drugs, like targretin. (bexarotene).