Leuprolide Acetate For Depot Suspension

Treats advanced prostate cancer. NDA 205054, held by Invagen Pharms. Leuprolide Acetate.

As of Nov 14, 2026, NDA 205054 (Leuprolide Acetate For Depot Suspension), held by Invagen Pharms, was first approved by FDA on Aug 28, 2018, with 4 approved supplements and 1 published complete response letter.

First approved: Aug 28, 2018
Review: Standard
Supplements approved: 4
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Feb 28, 2023	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 28, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
May 29, 2015	NDA 205054Clinical/Statistical, Product Quality, Facility Inspections	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
Leuprolide Acetate For Depot Suspension22.5MG/VIAL · for suspension;intramuscular	Leuprolide Acetate	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 8, 2024	Supplement 6Labeling · Standard review	Approved	Label Letter
Nov 30, 2023	Supplement 5Labeling · Standard review	Approved	Label Letter
Feb 28, 2023	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 28, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 205054
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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