Epilepsy
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CLINICAL_TRIALS trial_result · 2012-12-11Clinical Trial Update: Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study) [Phase 3]
Phase 3 trial assessing the efficacy and safety of adjunctive zonisamide in pediatric patients with partial-onset seizures; results were pos…
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CLINICAL_TRIALS trial_result · 2012-12-10Clinical Trial Update: Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures [Phase 3]
Open-label extension study of Rufinamide as adjunctive therapy in patients with refractory partial seizures; terminated with posted results …
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CLINICAL_TRIALS research · 2012-12-07Clinical Trial Update: A Pharmacogenomic Exploration of Lacosamide Response
This document describes an ongoing pharmacogenomic study investigating how genetic factors influence lacosamide response in epilepsy.
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CLINICAL_TRIALS research · 2012-11-30Clinical Trial Update: Multimodal Imaging in Pre-surgical Evaluation of Epilepsy
This document provides an update on a clinical trial evaluating multimodal imaging for pre-surgical evaluation in epilepsy.
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FDA approval · 2012-11-27FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for DILANTIN (extended phenytoin sodium) by Viatris Specialty LLC.
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FDA approval · 2012-11-27FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Phenytoin Infatabs from Prasco Laboratories.
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CLINICAL_TRIALS trial_result · 2012-11-22Clinical Trial Update: Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures [Phase 3]
Phase 3 trial evaluating the efficacy and safety of Perampanel (E2007) as adjunctive therapy for patients with refractory partial seizures; …
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CLINICAL_TRIALS trial_result · 2012-11-22Clinical Trial Update: Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures [Phase 2]
A Phase 2 study evaluating the safety and tolerability of E2007 up to 12 mg in patients with refractory partial seizures; results were poste…
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CLINICAL_TRIALS trial_result · 2012-11-21Clinical Trial Update: A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy [Phase 4]
Phase 4 trial assessing tolerability and efficacy of topiramate monotherapy in recently diagnosed epilepsy patients completed with results p…
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FDA approval · 2012-11-13FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)
The FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.
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FDA approval · 2012-11-09FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)
FDA approved a supplemental application for levetiracetam filed by WG Critical Care, LLC.
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CLINICAL_TRIALS withdrawal · 2012-11-01Clinical Trial Update: Seizure Therapy With Intravenous Levetiracetam and Lorazepam [Phase 2, Phase 3]
The Phase 2/3 clinical trial evaluating intravenous levetiracetam with lorazepam for seizure therapy has been withdrawn.
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FDA approval · 2012-10-29FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc. The approval pertains to changes…
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FDA approval · 2012-10-29FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc.
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FDA approval · 2012-10-25FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)
FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer Inc, indicating approval of changes to th…
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FDA approval · 2012-10-25FDA Approved: CLONAZEPAM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for clonazepam from Aurobindo Pharma Limited under an ANDA, confirming continued availability of thi…
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CLINICAL_TRIALS trial_result · 2012-10-24Clinical Trial Update: Seizure Advisory System Feasibility Study [Phase 1]
Phase 1 feasibility study of a Seizure Advisory System for epilepsy sponsored by NeuroVista Corporation has been terminated.
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CLINICAL_TRIALS trial_result · 2012-10-23Clinical Trial Update: An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures [Phase 3]
An open-label Phase 3 trial of pregabalin in subjects with refractory partial seizures was terminated; results were posted in 2012.
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FDA approval · 2012-10-22FDA Approved: FYCOMPA — Original Application (Eisai Inc.)
FDA approved FYCOMPA (perampanel) through Eisai's original NDA for treatment of seizures associated with epilepsy, beginning with partial-on…
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FDA approval · 2012-10-19FDA Approved: OXTELLAR XR — Original Application (Supernus Pharmaceuticals, Inc.)
FDA approves OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals as an original application for an extended-release formulation to tre…
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FDA label_change · 2012-10-19FDA Approved: PRIMIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for PRIMIDONE by Amneal Pharmaceuticals LLC, resulting in changes to the product labeling.
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FDA approval · 2012-10-19FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for Ethosuximide from Bionpharma Inc., confirming its use in treating absence seizures associate…
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CLINICAL_TRIALS trial_result · 2012-10-12Clinical Trial Update: Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures [Phase 3]
This update reports results from a Phase 3 trial evaluating adjunctive zonisamide in primary generalized tonic-clonic seizures. The study wa…
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FDA approval · 2012-09-25FDA Approved: ETHOSUXIMIDE — Original Application (Chartwell RX, LLC)
FDA approved Ethosuximide as an original generic (ANDA) for Chartwell RX, LLC.
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CLINICAL_TRIALS trial_result · 2012-09-17Clinical Trial Update: Clinical Evaluation of BW430C in Epilepsy [Phase 3]
Phase 3 clinical trial evaluating BW430C in epilepsy has completed with results posted.