Primidone

Overview

Primidone is an anticonvulsant used to treat essential tremor as well as grand mal, psychomotor, and focal epileptic seizures. Primidone was developed by J Yule Bogue and H C Carrington in 1949. Primidone was granted FDA Approval on 8 March 1954.

Indication

Primidone is commonly indicated for the management of grand mal, psychomotor, and focal epileptic seizures. In addition, it has also been studied and utilized as an effective management of essential tremor.

Associated Conditions

Essential Tremor
Generalized Tonic-Clonic Seizures
Partial-Onset Seizures
Temporal Lobe Epilepsy (TLE)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pathophysiology of Tremor-modulating Mechanisms of Propranolol and Primidone in Essential Tremor	2021/01/05	NCT04692844	N/A	Completed	University Medical Centre Ljubljana
Population Pharmacokinetics of Antiepileptic in Pediatrics	2017/06/22	NCT03196466	N/A	Recruiting	Assistance Publique - Hôpitaux de Paris
Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant	2013/12/11	NCT02008123	Phase 2	Withdrawn	Dent Neuroscience Research Center
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions	2010/05/27	NCT01132040	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets	2008/05/28	NCT00685165	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Primidone	PD-Rx Pharmaceuticals, Inc.	72789-178	ORAL	50 mg in 1 1	2/6/2024
Primidone	Aphena Pharma Solutions - Tennessee, LLC	71610-079	ORAL	50 mg in 1 1	7/2/2018
Primidone	Physicians Total Care, Inc.	54868-1691	ORAL	250 mg in 1 1	2/19/2013
PRIMIDONE	DIRECT RX	72189-216	ORAL	50 mg in 1 1	5/11/2021
PRIMIDONE	STAT Rx USA LLC	42549-680	ORAL	50 mg in 1 1	5/24/2012
Primidone	A-S Medication Solutions	50090-4083	ORAL	250 mg in 1 1	10/1/2021
Primidone	Aphena Pharma Solutions - Tennessee, LLC	71610-763	ORAL	50 mg in 1 1	1/9/2024
Primidone	Dr. Reddy's Laboratories Limited	55111-476	ORAL	250 mg in 1 1	12/2/2010
Mysoline	Bausch Health US, LLC	66490-691	ORAL	250 mg in 1 1	7/6/2020
Primidone	Aphena Pharma Solutions - Tennessee, LLC	71610-191	ORAL	50 mg in 1 1	1/25/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Mysoline Tablets	11231	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	7/11/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PRIMIDONE	aa pharma inc	00399310	Tablet - Oral	125 MG	12/31/1977
MYSOLINE PEDIATRIC CHEWABLE TABLETS 125MG	elan pharmaceuticals inc	02042363	Tablet - Oral	125 MG	12/31/1994
PRIMIDONE	aa pharma inc	00396761	Tablet - Oral	250 MG	12/31/1977
SERTAN TAB 250MG	Pharmascience Inc	00576719	Tablet - Oral	250 MG	12/31/1983
PRIMIDONE 250 TAB	PRO DOC LIMITEE	00563706	Tablet - Oral	250 MG / TAB	12/31/1982
MYSOLINE TAB 250MG	ayerst laboratories	00002631	Tablet - Oral	250 MG / TAB	12/31/1965
MYSOLINE TAB 125MG	ayerst laboratories	00002623	Tablet - Oral	125 MG / TAB	12/31/1963
MYSOLINE 250MG TAB	elan pharmaceuticals inc	02042355	Tablet - Oral	250 MG	12/31/1994
SERTAN TAB 125MG	Pharmascience Inc	00576700	Tablet - Oral	125 MG	12/31/1983
PRIMIDONE 125 TAB	PRO DOC LIMITEE	00563714	Tablet - Oral	125 MG / TAB	12/31/1982

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MYSOLINE 250 MG COMPRIMIDOS	Serb	18498	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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