Clobazam

Treats seizures associated with Lennox-Gastaut Syndrome (LGS). Sold as Onfi, Sympazan. Every FDA application for this active ingredient: 3 branded and 31 generic.

As of Nov 14, 2026, FDA lists 34 applications for Clobazam (sold as Onfi, Sympazan), first approved Oct 21, 2011, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 21, 2011
Applications: 34
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $53.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Onfi	Part D	$31.0M	-1%	1,086
Clobazam	Part D	$19.9M	-10%	23,674
Sympazan	Part D	$2.7M	+7%	214

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CLOBAZAM 10 MG TABLET: $0.244 per unitGeneric · -4% in a year
CLOBAZAM 2.5 MG/ML SUSPENSION: $0.182 per MLGeneric · -5% in a year
CLOBAZAM 20 MG TABLET: $0.376 per unitGeneric · -17% in a year
ONFI 10 MG TABLET: $29.89 per unitBrand · 0% in a year
ONFI 2.5 MG/ML SUSPENSION: $12.47 per MLBrand · 0% in a year
ONFI 20 MG TABLET: $59.79 per unitBrand · 0% in a year
SYMPAZAN 10 MG FILM: $32.76 per unitBrand · +2% in a year
SYMPAZAN 20 MG FILM: $65.43 per unitBrand · +2% in a year
SYMPAZAN 5 MG FILM: $16.40 per unitBrand · +2% in a year

FDA Drug Safety Communications

2 communications since 2020 that name this drug; see all communications

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of Lennox-Gastaut SyndromeLundbeck, Inc. · designated Dec 18, 2007 · approved Oct 21, 2011

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension · Duke University	—	Recruiting	Feb 20, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 21, 2011	OnfiNDA 202067 · New molecular entity	Lundbeck Pharms LLC	8	Marketed
Dec 14, 2012	OnfiNDA 203993 · New dosage form	Lundbeck Pharms LLC	9	Marketed
Oct 22, 2018	ClobazamANDA 208785	Hikma	3	Discontinued
Oct 22, 2018	ClobazamANDA 208819	Bionpharma	3	Marketed
Oct 22, 2018	ClobazamANDA 208825	Bionpharma	3	Marketed
Oct 22, 2018	ClobazamANDA 209308	Novitium Pharma	2	Discontinued
Oct 22, 2018	ClobazamANDA 209440	Taro	0	Discontinued
Oct 22, 2018	ClobazamANDA 209687	Upsher Smith Labs	3	Marketed
Oct 22, 2018	ClobazamANDA 209715	Hikma	3	Discontinued
Oct 22, 2018	ClobazamANDA 209795	Hetero Labs Ltd Iii	3	Marketed
Oct 22, 2018	ClobazamANDA 209808	Pharmazone	3	Marketed
Oct 22, 2018	ClobazamANDA 210039	Amneal	3	Marketed
Oct 22, 2018	ClobazamANDA 210569	Upsher Smith Labs	1	Discontinued
Oct 22, 2018	ClobazamANDA 211259	Pharmobedient	3	Discontinued
Oct 22, 2018	ClobazamANDA 211449	Zydus Pharms	0	Marketed
Oct 22, 2018	ClobazamANDA 209718	Amneal Pharms Co	4	Marketed
Nov 1, 2018	SympazanNDA 210833 · New dosage form	Cosette	5	Marketed
Dec 14, 2018	ClobazamANDA 210545	Lupin	3	Marketed
Dec 28, 2018	ClobazamANDA 210546	Lupin	3	Discontinued
Jan 30, 2019	ClobazamANDA 211711	Micro Labs	4	Marketed
Apr 15, 2019	ClobazamANDA 210978	Taro	2	Marketed
May 23, 2019	ClobazamANDA 212398	Accord Hlthcare	3	Discontinued
Jul 10, 2019	ClobazamANDA 210746	Vistapharm LLC	3	Discontinued
Sep 6, 2019	ClobazamANDA 212714	Alkem Labs Ltd	4	Marketed
Oct 30, 2019	ClobazamANDA 212092	Chartwell Molecular	0	Discontinued
Jan 31, 2020	ClobazamANDA 211032	Teva Pharms USA	1	Discontinued
Feb 24, 2020	ClobazamANDA 209796	Hetero Labs Ltd Iii	3	Marketed
Apr 24, 2020	ClobazamANDA 213110	Chartwell Molecular	1	Marketed
Jun 9, 2020	ClobazamANDA 209853	Apotex	3	Discontinued
Dec 9, 2020	ClobazamANDA 211959	Chartwell Rx	2	Discontinued
May 6, 2021	ClobazamANDA 213039	Alkem Labs Ltd	2	Marketed
May 11, 2021	ClobazamANDA 213404	Msn	2	Marketed
Mar 24, 2022	ClobazamANDA 214404	Aurobindo Pharma Ltd	2	Marketed
Sep 6, 2022	ClobazamANDA 216008	Accord Hlthcare	2	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA