Is Methoxsalen registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Methoxsalen.

Is Methoxsalen approved by the US FDA?

Drugs@FDA lists 7 application product lines for Methoxsalen, including OXSORALEN-ULTRA (Prescription); UVADEX (Prescription); METHOXSALEN (Prescription); 8-MOP (Discontinued); OXSORALEN (Discontinued).

Are there safety signals or safety updates for Methoxsalen?

US FDA: 1 entry (latest 2021-03-19).

Active substance

Methoxsalen

SFDA 4
US FDA 7
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NEO MELADININE F.R TAB 10MG	10 mg	Lozenge · Oral use	50 Blister	SAR 7.60	Generic · Prescription	MEMPHIS CHEMICALS	Withdrawn by regulatory authority · Not Marketed
OXSORALEN CAPS 10MG	10 mg	Capsule · Oral use	100 Tablet Container	SAR 64.60	NCE · Prescription	I.C.N.PHARMACEUTICALS	Invalid · Not Marketed
OXSORALEN CAPS 10MG	10 mg	Capsule · Oral use	30 Blister	SAR 21.80	NCE · Prescription	I.C.N.PHARMACEUTICALS	Invalid · Not Marketed
OXSORALEN LOTION	1 %	Solution · Topical	1 Bottle	SAR 39.95	NCE · Prescription	I.C.N.PHARMACEUTICALS	Invalid · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OXSORALEN-ULTRA	10MG	capsule · oral	BAUSCH	Prescription	30 Oct 1986
UVADEX	0.02MG/ML	injectable · injection	THERAKOS DEVELOPMENT	Prescription	25 Feb 1999
METHOXSALEN	10MG	capsule · oral	ONESOURCE	Prescription	5 Jun 2014
8-MOP	10MG	capsule · oral	VALEANT PHARM INTL	Discontinued	3 Dec 1954
OXSORALEN	1%	lotion · topical	VALEANT PHARM INTL	Discontinued	3 Dec 1954
METHOXSALEN	10MG	capsule · oral	ACTAVIS INC	Discontinued	9 Jun 2015
METHOXSALEN	10MG	capsule · oral	ANI PHARMS	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
UVADEX	02406233	20 MCG / ML	SOLUTION · EXTRACORPOREAL	THERAKOS LLC

Safety signals and safety-related labeling changes

US FDA 19 Mar 2021 UVADEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for methoxsalen →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.