Supprelin La

Treats central precocious puberty (CPP). NDA 22058, held by Endo Operations. Histrelin Acetate.

As of Nov 15, 2026, NDA 22058 (Supprelin La), held by Endo Operations, was first approved by FDA on May 3, 2007, with 12 approved supplements and 0 published complete response letters.

First approved: May 3, 2007
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment.

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
May 3, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Supprelin La50MG · implant;subcutaneous	Histrelin Acetate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 20Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 22, 2022	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 8, 2019	Supplement 16Labeling · Standard review	Approved	Letter Label
May 19, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
May 19, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 21, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 19, 2013	Supplement 8Manufacturing · Standard review	Approved	Label
Apr 2, 2013	Supplement 11Labeling · Standard review	Approved	Label Letter
Apr 5, 2012	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 30, 2011	Supplement 6Labeling · Standard review	Approved	Label Letter
Jul 2, 2008	Supplement 3Manufacturing	Approved	Label Letter
Nov 21, 2007	Supplement 1Labeling · Standard review	Approved	Letter
May 3, 2007	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22058
Drugs@FDA: Overview at FDA
Company: Endo Operations

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