Ganirelix Acetate

NDA 21057, held by Organon USA Organon. Ganirelix Acetate.

As of Nov 14, 2026, NDA 21057 (Ganirelix Acetate), held by Organon USA Organon, was first approved by FDA on Jul 29, 1999, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1999
Review: Priority
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 29, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ganirelix Acetate250MCG/0.5ML · injectable;injection	Ganirelix Acetate	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Sep 23, 2024	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 14, 2023	Supplement 21Labeling · Standard review	Approved	Label Letter
Aug 14, 2023	Supplement 19Labeling · Standard review	Approved	Label Letter
Aug 14, 2023	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 14, 2023	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 22, 2020	Supplement 20Labeling · Standard review	Approved	Label Letter
May 3, 2016	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 10, 2016	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 12, 2015	Supplement 13Manufacturing · Priority review	Approved	None posted
Dec 19, 2014	Supplement 10Labeling	Approved	Label Letter
Jun 30, 2008	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 20, 2002	Supplement 3Manufacturing · Priority review	Approved	None posted
Jun 7, 2001	Supplement 1Manufacturing · Priority review	Approved	None posted
May 15, 2001	Supplement 2Labeling · Standard review	Approved	None posted
Jul 29, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21057
Drugs@FDA: Overview at FDA
Company: Organon USA Organon

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