Edex

Treats erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed…. NDA 20649, held by Endo Operations. Alprostadil.

As of Nov 13, 2026, NDA 20649 (Edex), held by Endo Operations, was first approved by FDA on Jun 12, 1997, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 12, 1997
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE edex is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 12, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

7 strengths and forms

Product	Active ingredient	Marketing
Edex0.005MG/VIAL · injectable;injection	Alprostadil	Discontinued
Edex0.01MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Edex0.02MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Edex0.04MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Edex0.01MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Edex0.02MG/VIAL · injectable;injection	Alprostadil	RxReference drug
Edex0.04MG/VIAL · injectable;injection	Alprostadil	RxReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 17, 2016	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 9, 2015	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 12, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 11, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 9, 2006	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 14, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 31, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 1, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 10, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 19, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 20, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 20, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 15, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 6, 1999	Supplement 9Labeling · Standard review	Approved	None posted
Sep 22, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 30, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 1, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 5, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 12, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20649
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