Emend

NDA 22023, held by Merck And Co Inc. Fosaprepitant Dimeglumine.

As of Nov 14, 2026, NDA 22023 (Emend), held by Merck And Co Inc, was first approved by FDA on Jan 25, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2008
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EMEND for injection, in combination with other antiemetic agents, is indicated in adults and pediatric 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. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


May 2, 2022	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 3, 2018	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Label Letter Pediatric Medical Review
Feb 1, 2016	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 12, 2010	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jan 25, 2008	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter Pediatric Written Request

Products

2 strengths and forms


EmendEQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intravenous	Fosaprepitant Dimeglumine	DiscontinuedReference drug
EmendEQ 150MG BASE/VIAL · powder;intravenous	Fosaprepitant Dimeglumine	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


May 2, 2022	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 14, 2019	Supplement 19Labeling · Standard review	Approved	Letter Label
Apr 3, 2018	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Label Letter Pediatric Medical Review
Mar 26, 2018	Supplement 18Labeling · Standard review	Approved	Review Letter Label
Aug 9, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
May 31, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 2, 2016	Supplement 14Manufacturing	Approved	Review Label
Feb 1, 2016	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 12, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 12, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 27, 2013	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 20, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 6, 2012	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 12, 2010	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 23, 2010	Supplement 2Labeling · Standard review	Approved	Label Letter
Mar 23, 2010	Supplement 3Labeling · Standard review	Approved	Label Letter
Mar 23, 2010	Supplement 5Labeling	Approved	Label Letter
Feb 2, 2009	Supplement 1Labeling · Standard review	Approved	None posted
Jan 25, 2008	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter Pediatric Written Request

Identifiers

Application: NDA 22023
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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