|
Device | UVAR XTS PHOTOPHERESIS SYSTEM |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S040 |
Date Received | 03/15/2002 |
Decision Date | 04/12/2002 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | 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). |