Is Bexarotene approved by the US FDA?

Drugs@FDA lists 11 application product lines for Bexarotene, including TARGRETIN (Prescription); TARGRETIN (Prescription); BEXAROTENE (Prescription); BEXAROTENE (Prescription); BEXAROTENE (Prescription).

Is Bexarotene authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bexarotene: Targretin.

Active substance

Bexarotene

US FDA 11
EMA 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
TARGRETIN	75MG	capsule · oral	BAUSCH	Prescription	29 Dec 1999
TARGRETIN	1%	gel · topical	BAUSCH	Prescription	28 Jun 2000
BEXAROTENE	75MG	capsule · oral	BIONPHARMA	Prescription	12 Aug 2014
BEXAROTENE	75MG	capsule · oral	ANI PHARMS	Prescription	8 May 2018
BEXAROTENE	75MG	capsule · oral	UPSHER SMITH LABS	Prescription	25 Jul 2018
BEXAROTENE	75MG	capsule · oral	AMNEAL PHARMS NY	Prescription	4 Sep 2018
BEXAROTENE	75MG	capsule · oral	TEVA PHARMS USA	Prescription	14 Jan 2021
BEXAROTENE	1%	gel · topical	AMNEAL	Prescription	27 Apr 2022
BEXAROTENE	75MG	capsule · oral	ASCENT PHARMS INC	Prescription	6 Sep 2024
BEXAROTENE	75MG	capsule · oral	HIKMA PHARMS	Discontinued	16 Jun 2020
BEXAROTENE	75MG	capsule · oral	CIPLA	Discontinued	10 Dec 2024

EMA European Union — centrally authorised medicines

Targretin H.A.C. Pharma · Authorised · authorised 29 Mar 2001 · ATC L01XF03

Therapeutic indication (EMA)

Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.

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.