Is Desogestrel + Ethinylestradiol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Desogestrel + Ethinylestradiol, including CYBELLE FILM COATED TABLET (30,150 µg,µg, Film-coated tablet, SAR 10.20); GRACIAL TABLET (0.025,0.03 mg,mg, Tablet, SAR 19.60); MARVELON TAB (150,30 µg,µg, Tablet, SAR 14.60); REGULON (150,30 µg,µg, Film-coated tablet, SAR 10.20).

Is Desogestrel + Ethinylestradiol approved by the US FDA?

Drugs@FDA lists 34 application product lines for Desogestrel + Ethinylestradiol, including DESOGESTREL AND ETHINYL ESTRADIOL (Prescription); CYCLESSA (Prescription); KARIVA (Prescription); VELIVET (Prescription); DESOGESTREL; ETHINYL (Prescription).

Active substances

Desogestrel + Ethinylestradiol

SFDA 7
US FDA 34
Health Canada 12
US price lines 8
NHS prices 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CYBELLE FILM COATED TABLET	30,150 µg,µg	Film-coated tablet · Oral use	28 Blister	SAR 10.20	Generic · Prescription	Exeltis Healthcare S.L	Valid
GRACIAL TABLET	0.025,0.03 mg,mg	Tablet · Oral use	22 Blister	SAR 19.60	Generic · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Valid
MARVELON TAB	150,30 µg,µg	Tablet · Oral use	21 Blister	SAR 14.60	Generic · Prescription	ORGANON	Valid
REGULON	150,30 µg,µg	Film-coated tablet · Oral use	21 Blister	SAR 10.20	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
GRACIAL TABLET	0.03, 0.025 mg	Tablet · Oral use	22 Blister	SAR 21.85	Generic · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
MARVELON TAB	30, 150 µg	Tablet · Oral use	63 Blister	SAR 32.65	Generic · Prescription	ORGANON	Withdrawn by MAH · Not Marketed
REGULON	30, 150 µg	Film-coated tablet · Oral use	63 Blister	SAR 22.85	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CONTRACEPTION; ENDOMETRIOSIS; HYPERPROLACTINEMIA; MENOPAUSE; MENSTRUAL DISORDERS

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

Product	Strength	Form · route	Applicant	Status	First approved
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	tablet · oral-28	DURAMED PHARMS BARR	Prescription	12 Aug 1999
CYCLESSA	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	tablet · oral-28	ASPEN GLOBAL INC	Prescription	20 Dec 2000
KARIVA	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	BARR	Prescription	5 Apr 2002
VELIVET	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	tablet · oral-28	DURAMED PHARMS BARR	Prescription	24 Feb 2004
DESOGESTREL; ETHINYL	0.125MG/0.025MG; 0.15MG/0.025MG	tablet · oral	DURAMED PHARMS BARR	Prescription	24 Feb 2004
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	tablet · oral-28	WATSON LABS	Prescription	29 Jul 2005
DESOGESTREL; ETHINYL ESTRADIOL	0.125MG/0.025MG; 0.15MG/0.025MG	tablet · oral-28	DR REDDYS LABS SA	Prescription	24 Jan 2006
VIORELE	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	GLENMARK PHARMS LTD	Prescription	2 Apr 2012
ENSKYCE	0.15MG;0.03MG	tablet · oral-28	LUPIN LTD	Prescription	7 Mar 2013
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	tablet · oral-28	NOVAST LABS	Prescription	12 Jul 2013
PIMTREA	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	NOVAST LABS	Prescription	1 Aug 2013
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	XIROMED	Prescription	30 Aug 2013
BEKYREE	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	LUPIN	Prescription	12 Aug 2015
ISIBLOOM	0.15MG;0.03MG	tablet · oral-28	XIROMED	Prescription	12 Aug 2015
VOLNEA	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	XIROMED	Prescription	9 Sep 2016
SIMLIYA	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	AUROBINDO PHARMA	Prescription	22 Mar 2017
KALLIGA	0.15MG;0.03MG	tablet · oral-28	AUROBINDO PHARMA	Prescription	17 May 2017
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	NAARI PTE	Prescription	5 Jun 2017
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	tablet · oral-28	NAARI PTE	Prescription	13 Sep 2018
AVERI	0.15MG;0.03MG	tablet · oral-21	AVION PHARMS	Prescription	2 May 2025
AVERI	0.15MG;0.03MG	tablet · oral-28	AVION PHARMS	Prescription	2 May 2025
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG;0.03MG	tablet · oral-28	ANNORA PHARMA	Prescription	18 Mar 2026
DESOGESTREL AND ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	tablet · oral-28	ANNORA PHARMA	Prescription	7 Jul 2026
DESOGEN	0.15MG;0.03MG	tablet · oral-21	ORGANON USA INC	Discontinued	10 Dec 1992
DESOGEN	0.15MG;0.03MG	tablet · oral-28	ORGANON USA INC	Discontinued	10 Dec 1992

9 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APRI 21	02317192	0.15 MG; 0.03 MG	TABLET · ORAL	TEVA CANADA LIMITED
APRI 28	02317206	0.03 MG; 0.15 MG	TABLET · ORAL	TEVA CANADA LIMITED
FREYA 21	02396491	0.15 MG; 0.03 MG	TABLET · ORAL	SENADOR LABORATORIES PRIVATE LIMITED
FREYA 28	02396610	0.03 MG; 0.15 MG	TABLET · ORAL	SENADOR LABORATORIES PRIVATE LIMITED
LINESSA 21	02272903	0.025 MG; 0.15 MG; 0.125 MG; 0.1 MG	TABLET · ORAL	ASPEN PHARMACARE CANADA INC.
LINESSA 28	02257238	0.1 MG; 0.025 MG; 0.125 MG; 0.15 MG	TABLET · ORAL	ASPEN PHARMACARE CANADA INC.
MARVELON 21	02042487	0.15 MG; 0.03 MG	TABLET · ORAL	ORGANON CANADA INC.
MARVELON 28	02042479	0.15 MG; 0.03 MG	TABLET · ORAL	ORGANON CANADA INC.
MILEY 21	02556553	0.15 MG; 0.03 MG	TABLET · ORAL	AMBICARE PHARMACEUTICALS INC.
MILEY 28	02556561	0.03 MG; 0.15 MG	TABLET · ORAL	AMBICARE PHARMACEUTICALS INC.
MIRVALA 21	02410249	0.1500 MG / TAB; 0.0300 MG / TAB	TABLET · ORAL	APOTEX INC
MIRVALA 28	02410257	0.1500 MG / TAB; 0.0300 MG / TAB	TABLET · ORAL	APOTEX INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ENSKYCE 28 TABLET	$0.13531	per EA	23 Sep 2026
US NADAC	ISIBLOOM 28 DAY TABLET	$0.13531	per EA	23 Sep 2026
US NADAC	KARIVA 28 DAY TABLET	$0.17245	per EA	23 Sep 2026
US NADAC	PIMTREA 28 DAY TABLET	$0.17245	per EA	23 Sep 2026
US NADAC	SIMLIYA 28 DAY TABLET	$0.17245	per EA	23 Sep 2026
US NADAC	VELIVET 28 DAY TABLET	$0.53646	per EA	23 Sep 2026
US NADAC	VIORELE 28 DAY TABLET	$0.17245	per EA	23 Sep 2026
US NADAC	VOLNEA 0.15-0.02-0.01 MG TAB	$0.17245	per EA	23 Sep 2026
NHS Drug Tariff	Ethinylestradiol 20microgram / Desogestrel 150microgram tablets	£5.98	63 tablet	1 Oct 2026
NHS Drug Tariff	Ethinylestradiol 30microgram / Desogestrel 150microgram tablets	£4.93	63 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.

Components

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.