Trelstar

Treats advanced prostate cancer. NDA 22437, held by Verity. Triptorelin Pamoate.

As of Nov 13, 2026, NDA 22437 (Trelstar), held by Verity, was first approved by FDA on Mar 10, 2010, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 10, 2010
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRELSTAR is indicated for the treatment of advanced prostate cancer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 10, 2010	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
TrelstarEQ 22.5MG BASE/VIAL · injectable;intramuscular	Triptorelin Pamoate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Jun 26, 2026	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 23, 2025	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 11, 2025	Supplement 25Labeling · Standard review	Approved	Label Letter
Apr 12, 2024	Supplement 24Labeling · Standard review	Approved	Label Letter
Nov 17, 2023	Supplement 22Labeling · Standard review	Approved	Label Letter
Mar 3, 2023	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 14, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 26, 2015	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 20, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 11, 2014	Supplement 8Labeling · Standard review	Approved	Letter Label
Jul 3, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 25, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 11, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 12, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
May 19, 2011	Supplement 3Labeling	Approved	Letter Label
Jan 14, 2011	Supplement 2Labeling	Approved	Letter Label
Mar 10, 2010	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22437
Drugs@FDA: Overview at FDA
Company: Verity 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