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Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant	2013/12/11	NCT02008123	Phase 2	Withdrawn	Dent Neuroscience Research Center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
Primidone Tablets	原研药港生物制药（沈阳）股份有限公司	国药准字H21022464	化学药品	片剂	8/26/2020
Primidone Tablets	江西制药有限责任公司	国药准字H36020818	化学药品	片剂	2/22/2021
Primidone Tablets	原研药港生物制药（沈阳）股份有限公司	国药准字H21021821	化学药品	片剂	8/26/2020
Primidone Tablets	吉林万通药业有限公司	国药准字H22021340	化学药品	片剂	2/13/2020
Primidone Tablets	远大医药（中国）有限公司	国药准字H42021889	化学药品	片剂	6/10/2020
Primidone Tablets	原研药港生物制药（沈阳）股份有限公司	国药准字H21021820	化学药品	片剂	8/26/2020
Primidone Tablets	瑞阳制药股份有限公司	国药准字H37021919	化学药品	片剂	4/2/2020
Primidone Tablets	北京海王中新药业股份有限公司	国药准字H13020682	化学药品	片剂	1/15/2021
Primidone Tablets	江西制药有限责任公司	国药准字H36020817	化学药品	片剂	2/22/2021
Primidone Tablets	华润紫竹药业有限公司	国药准字H11020462	化学药品	片剂	11/26/2020

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

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