Uvadex

NDA 20969, held by Therakos Development. Methoxsalen.

As of Nov 13, 2026, NDA 20969 (Uvadex), held by Therakos Development, was first approved by FDA on Feb 25, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1999
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 25, 1999	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Uvadex0.02MG/ML · injectable;injection	Methoxsalen	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Mar 19, 2021	Supplement 14Labeling · Standard review	Approved	Label Letter
Jan 9, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 1, 2013	Supplement 6Labeling · Standard review	Approved	Letter Label
Jun 5, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 25, 1999	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 20969
Drugs@FDA: Overview at FDA
Company: Therakos

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