NDA 21227, held by Merck. Caspofungin Acetate.
As of Nov 15, 2026, NDA 21227 (Cancidas), held by Merck, was first approved by FDA on Jan 26, 2001, with 30 approved supplements and 0 published complete response letters.
CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients. Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. Treatment of esophageal candidiasis. Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. 1.
| Jun 26, 2009 | Supplement 23Efficacy (new indication or use) | Approved | |
| Jul 29, 2008 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Feb 16, 2005 | Supplement 15Efficacy (new indication or use) | Approved | |
| Sep 29, 2004 | Supplement 12Efficacy (new indication or use) | Approved | |
| Jan 7, 2003 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2001 | Original applicationNew molecular entity · Priority review | Approved |
| Cancidas50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · powder;intravenous | Caspofungin Acetate | DiscontinuedReference drug |
| Cancidas70MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · powder;intravenous | Caspofungin Acetate | DiscontinuedReference drug |
| Oct 25, 2021 | Supplement 40Labeling · Standard review | Approved | |
| Feb 8, 2019 | Supplement 39Labeling · Standard review | Approved | |
| Mar 13, 2018 | Supplement 38Labeling · Standard review | Approved | |
| Aug 25, 2017 | Supplement 37Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 36Labeling · Standard review | Approved | |
| Apr 12, 2016 | Supplement 35Labeling · Standard review | Approved | |
| Apr 12, 2016 | Supplement 34Labeling · Standard review | Approved | |
| Oct 23, 2014 | Supplement 33Labeling · Standard review | Approved | |
| Dec 18, 2013 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Aug 2, 2013 | Supplement 30Labeling · Standard review | Approved | |
| Jan 8, 2013 | Supplement 31Labeling · Standard review | Approved | |
| Apr 30, 2012 | Supplement 29Labeling · Standard review | Approved | |
| Oct 22, 2010 | Supplement 28Labeling | Approved | |
| Jan 28, 2010 | Supplement 27Labeling | Approved | |
| Jun 26, 2009 | Supplement 23Efficacy (new indication or use) | Approved | |
| May 4, 2009 | Supplement 24Labeling · Standard review | Approved | |
| Jul 29, 2008 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Jul 21, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Feb 16, 2005 | Supplement 15Efficacy (new indication or use) | Approved | |
| Sep 29, 2004 | Supplement 12Efficacy (new indication or use) | Approved | |
| Mar 17, 2004 | Supplement 14Labeling · Standard review | Approved | |
| Mar 17, 2004 | Supplement 11Labeling · Standard review | Approved | |
| Jan 7, 2003 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Dec 10, 2002 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 21, 2002 | Supplement 5Labeling · Standard review | Approved | |
| Nov 15, 2002 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Sep 20, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Sep 20, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2002 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Apr 11, 2002 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 26, 2001 | Original applicationNew molecular entity · Priority 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
