|
Trade Name | LIPOSORBER LA-15 System |
Classification Name | apheresis for focal glomerulosclerosis in adult and pediatric patients |
Generic Name | apheresis for focal glomerulosclerosis in adult and pediatric patients |
Applicant |
Kaneka Pharma America LLC |
546 fifth avenue, 21st floor |
new york, NY 10036 |
|
HDE Number | H170002 |
Date Received | 06/16/2017 |
Decision Date | 03/20/2018 |
Product Code | |
Docket Number | 18M-1215 |
Notice Date | 04/11/2018 |
Advisory Committee |
Gastroenterology |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the liposorber® la-15 system to expand the indication to include adult patients with nephrotic syndrome. The liposorber® la-15 is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a gfr >= 60 ml/min/1. 73m2 or the patient is post renal transplantation. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Probable Benefit
|
Labeling |
Labeling
Labeling Part 2
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 |