Manages kidney failure. NDA 21321, held by Vantive US Hlthcare. Icodextrin.
As of Nov 15, 2026, NDA 21321 (Extraneal), held by Vantive US Hlthcare, was first approved by FDA on Dec 20, 2002, with 18 approved supplements and 0 published complete response letters.
EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET).
| Dec 17, 2004 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2002 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Extraneal7.5GM/100ML · solution;intraperitoneal | Icodextrin | RxReference drug |
| Apr 22, 2024 | Supplement 38Labeling · Standard review | Approved | |
| Dec 4, 2019 | Supplement 37REMS | Approved | |
| Dec 16, 2016 | Supplement 34Labeling · Standard review | Approved | |
| Oct 24, 2016 | Supplement 35REMS | Approved | |
| Aug 1, 2016 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 16, 2015 | Supplement 32REMS | Approved | |
| Dec 9, 2014 | Supplement 28Labeling · Standard review | Approved | |
| Feb 25, 2014 | Supplement 29REMS | Approved | |
| Feb 4, 2014 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Apr 26, 2013 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2011 | Supplement 21Labeling | Approved | |
| Mar 9, 2011 | Supplement 20REMS · Standard review | Approved | |
| Apr 7, 2009 | Supplement 17Labeling | Approved | |
| Jan 29, 2009 | Supplement 18Manufacturing | Approved | |
| Feb 23, 2007 | Supplement 13Labeling · Standard review | Approved | |
| May 24, 2005 | Supplement 9Labeling · Standard review | Approved | |
| May 24, 2005 | Supplement 8Manufacturing · Standard review | Approved | |
| Dec 17, 2004 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2002 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
