Plenaxis

NDA 21320, held by Speciality European. Abarelix.

As of Nov 14, 2026, NDA 21320 (Plenaxis), held by Speciality European, was first approved by FDA on Nov 25, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 25, 2003
Review: Priority
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 25, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Plenaxis100MG/VIAL · powder;intramuscular	Abarelix	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 8, 2005	Supplement 2Labeling · Priority review	Approved	Letter Label
Nov 25, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21320
Drugs@FDA: Overview at FDA
Company: Speciality European Pharma

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