Zonisamide is a sulfonamide anticonvulsant approved for use as an adjunct therapy in adults with partial-onset seizures. It was discovered by researchers at Dainippon Sumitomo Pharma (大日本住友製薬: Dainippon Sumitomo Seiyaku (formerly Dainippon Pharmaceutical (大日本製薬: Dainippon Seiyaku)), who launched it in 1989 as Excegran® in Japan. It was marketed by Élan in the United States starting in 2000 as Zonegran®, before Élan transferred their interests in zonisamide to Eisai (エーザイ) in 2004. Eisai also markets Zonegran® in Asia (China, Taiwan, and fourteen others) and Europe (starting in Germany and the United Kingdom).
Uses
Approved
Zonisamide is approved in the United States,
United Kingdom,
for adjunctive treatment of partial seizures in adults and in Japan for both adjunctive and monotherapy for partial seizures (simple, complex, secondarily generalized), generalized (tonic, tonic-clonic (grand mal), and atypical absence) and combined seizures.
Unapproved/Off-Label/Investigational
An open trial on zonisamide in seven
Parkinson's disease patients had positive results, according to this 2001 report.
Since then, it has been reported to treat the resting
tremor that other therapies may leave behind.
By early November of 2005, Dainippon Sumitomo had filed a
NDA for the use of zonisamide in Parkinson's disease; it is to be marketed as Tremode®.
It has also been studied for obesity[ | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=12684361&dopt=ExternalLink}}] with significant positive effects on body weight and there are three ongoing clinical trials for this indication.,,
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[ Zonisamide ]
CFDA: FDA Latest Computer Systems Warning LettersWL Issued to Amrex Zetron IncFDA Tue, 14 Apr 2009 00:00:00 -0400
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CFDA: FDA Latest Drug GCP Warning LettersWL Issued to Coast Institutional Review BoardFDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MDFDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
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FDA Warning Letter Issued to Bukowski, Ronald M, MD on 30 Mar 2009 by Center for Drug Evaluation and Research
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FDA Warning Letter Issued to Youabian, Inc on 17 Mar 2009 by Los Angeles District Office
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FDA Warning Letter Issued to Provena St. Joseph's Medical Center IRB on 12 Mar 2009 by Center for Biologics Evaluation and Research
WL Issued to Paulson, Daniel M., MDFDA Wed, 11 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Paulson, Daniel M., MD on 11 Mar 2009 by Center for Drug Evaluation and Research
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Zonegran (Zonisamide) Capsules: Newly Approved Drug Therapies - Profile prepared at the time of US FDA approval, from CenterWatch Clinical Trials Listing Service. Discusses uses, results of clinical testing, side effects, and mechnisms of action.
Meta Description: [ Listing for Zonegran (zonisamide) Capsules in FDA Approved Drug Therapies Archives from CenterWatch Clinical Trials Listing Service ]
Zonisamide - Medline Plus - Information for consumers including proper use, precautions, and storage recommendations.
Meta Description: [ Zonisamide(Systemic) ]