|
Trade Name | LIXELLE® ß2-microgliblin Apheresis Column |
Classification Name | beta 2-microglobulin apheresis column |
Generic Name | beta 2-microglobulin apheresis column |
Applicant |
KANEKA PHARMA AMERICA LLC |
546 fifth ave., 21st floor |
new york, NY 10036 |
|
HDE Number | H130001 |
Supplement Number | S003 |
Date Received | 03/10/2023 |
Decision Date | 12/18/2023 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the labeling of the lixelle® ß2-microgliblin apheresis column regarding the conditions of use to allow a blood flow rate (qb) of up to 450 ml/min, which is currently set at 250 ml/min. |