Firmagon

Treats advanced prostate cancer. NDA 22201, held by Ferring. Degarelix Acetate.

As of Nov 13, 2026, NDA 22201 (Firmagon), held by Ferring, was first approved by FDA on Dec 24, 2008, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 24, 2008
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FIRMAGON is indicated for treatment of patients with advanced prostate cancer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 24, 2008	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
FirmagonEQ 80MG BASE/VIAL · powder;subcutaneous	Degarelix Acetate	RxReference drug
FirmagonEQ 120MG BASE/VIAL · powder;subcutaneous	Degarelix Acetate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 24, 2020	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 21, 2016	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 12, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 27, 2015	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 31, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 26, 2015	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 15, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 10, 2014	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 25, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 16, 2013	Supplement 3Labeling · Standard review	Approved	Label Letter
Mar 5, 2013	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 24, 2008	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22201
Drugs@FDA: Overview at FDA
Company: Ferring Pharmaceuticals

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