Is Darifenacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Darifenacin, including ENABLEX 15MG PROLONGED RELEASE TABLETS (15 mg, Prolonged-release tablet, SAR 133.30); ENABLEX 7.5MG PROLONGED RELEASE TABLETS (7.5 mg, Prolonged-release tablet, SAR 133.30).

Is Darifenacin approved by the US FDA?

Drugs@FDA lists 10 application product lines for Darifenacin, including DARIFENACIN HYDROBROMIDE (Prescription); DARIFENACIN HYDROBROMIDE (Prescription); DARIFENACIN HYDROBROMIDE (Prescription); DARIFENACIN (Prescription); DARIFENACIN HYDROBROMIDE (Prescription).

Is Darifenacin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Darifenacin: Emselex.

Are there safety signals or safety updates for Darifenacin?

US FDA: 1 entry (latest 2021-07-14).

Active substance

Darifenacin

SFDA 4
US FDA 10
EMA 1
Health Canada 6
US price lines 2
NHS prices 2
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
ENABLEX 15MG PROLONGED RELEASE TABLETS	15 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 133.30	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Valid
ENABLEX 7.5MG PROLONGED RELEASE TABLETS	7.5 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 133.30	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Valid
ENABLEX 15MG PROLONGED RELEASE TABLETS	15 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 189.45	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
ENABLEX 7.5MG PROLONGED RELEASE TABLETS	7.5 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 171.30	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; URINARY INCONTINENCE AND OVERACTIVE BLADDER

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

Product	Strength	Form · route	Applicant	Status	First approved
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	CIPLA	Prescription	1 Sep 2016
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	AUROBINDO PHARMA	Prescription	19 Sep 2016
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	TORRENT	Prescription	17 Nov 2016
DARIFENACIN	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	MACLEODS PHARMS	Prescription	28 Jul 2017
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	ALEMBIC	Prescription	8 Dec 2017
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	PURACAP LABS BLU	Prescription	6 Jan 2020
ENABLEX	EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	ABBVIE	Discontinued	22 Dec 2004
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	PH HEALTH	Discontinued	13 Mar 2015
DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE; EQ 15MG BASE	tablet, extended release · oral	JUBILANT GENERICS	Discontinued	12 Oct 2016
DARIFENACIN HYDROBROMIDE	EQ 15MG BASE; EQ 7.5MG BASE	tablet, extended release · oral	XIROMED	Discontinued	22 Oct 2019

EMA European Union — centrally authorised medicines

Emselex pharmaand GmbH · Authorised · authorised 22 Oct 2004 · ATC G04BD10

Therapeutic indication (EMA)

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DARIFENACIN	02452510	7.5 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-DARIFENACIN	02452529	15 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
ENABLEX	02273217	7.5 MG	TABLET (EXTENDED-RELEASE) · ORAL	SEARCHLIGHT PHARMA INC
ENABLEX	02273225	15 MG	TABLET (EXTENDED-RELEASE) · ORAL	SEARCHLIGHT PHARMA INC
JAMP DARIFENACIN	02491869	7.5 MG	TABLET (EXTENDED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
JAMP DARIFENACIN	02491877	15 MG	TABLET (EXTENDED-RELEASE) · ORAL	JAMP PHARMA CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DARIFENACIN ER 15 MG TABLET	$0.43232	per EA	23 Sep 2026
US NADAC	DARIFENACIN ER 7.5 MG TABLET	$0.54943	per EA	23 Sep 2026
NHS Drug Tariff	Darifenacin 15mg modified-release tablets	£25.48	28 tablet	1 Oct 2026
NHS Drug Tariff	Darifenacin 7.5mg modified-release tablets	£25.48	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 14 Jul 2021 ENABLEX — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for darifenacin →

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.