NDA 21549, held by Msd. Aprepitant.
As of Nov 14, 2026, NDA 21549 (Emend), held by Msd, was first approved by FDA on Mar 26, 2003, with 21 approved supplements and 0 published complete response letters.
EMEND for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
| Aug 28, 2015 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2010 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Jun 30, 2006 | Supplement 10Efficacy (new indication or use) | Approved | |
| Oct 28, 2005 | Supplement 8Efficacy (new indication or use) | Approved | |
| Mar 26, 2003 | Original applicationNew molecular entity · Priority review | Approved |
| Emend80MG · capsule;oral | Aprepitant | RxReference drug |
| Emend125MG · capsule;oral | Aprepitant | RxReference drug |
| Emend40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Aprepitant | DiscontinuedReference drug |
| Nov 14, 2019 | Supplement 30Labeling · Standard review | Approved | |
| Sep 25, 2019 | Supplement 31Labeling · Standard review | Approved | |
| May 31, 2017 | Supplement 27Labeling · Standard review | Approved | |
| Aug 28, 2015 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Jan 12, 2015 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 12, 2014 | Supplement 24Labeling · Standard review | Approved | |
| Mar 27, 2013 | Supplement 23Labeling · Standard review | Approved | |
| Mar 20, 2013 | Supplement 19Labeling · Standard review | Approved | |
| Jul 6, 2012 | Supplement 21Labeling · Standard review | Approved | |
| Mar 19, 2010 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Jul 21, 2009 | Supplement 14Labeling · Standard review | Approved | |
| Feb 2, 2009 | Supplement 16Labeling · Standard review | Approved | |
| Nov 18, 2008 | Supplement 15Labeling · Standard review | Approved | |
| Nov 15, 2007 | Supplement 12Labeling · Standard review | Approved | |
| Jun 30, 2006 | Supplement 10Efficacy (new indication or use) | Approved | |
| Jun 9, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Oct 28, 2005 | Supplement 8Efficacy (new indication or use) | Approved | |
| Jun 9, 2005 | Supplement 9Labeling · Standard review | Approved | |
| Dec 22, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Dec 15, 2004 | Supplement 4Labeling · Standard review | Approved | |
| Jan 15, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Mar 26, 2003 | 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
