Epilepsy
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CLINICAL_TRIALS trial_result · 2014-08-08Clinical Trial Update: Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures [Phase 4]
Phase 4 comparative study of pregabalin vs gabapentin as adjunctive therapy in partial seizures completed with results posted in 2014.
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FDA approval · 2014-08-07FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc. The approval pertains to the changes described in …
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FDA approval · 2014-08-07FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, Inc., expanding its approved use/label for this extended…
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CLINICAL_TRIALS trial_result · 2014-08-07Clinical Trial Update: Heart Rate Changes in Subjects With Epilepsy
A completed clinical trial evaluated heart rate changes in epilepsy patients treated with vagus nerve stimulation (VNS Therapy), with result…
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FDA approval · 2014-08-07FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc.
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CLINICAL_TRIALS trial_result · 2014-08-07Clinical Trial Update: 3-Dimensional Accelerometer Sub-Study [NA]
This document notes the completion of a 3-Dimensional Accelerometer Sub-Study within an epilepsy trial sponsored by Cyberonics.
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FDA approval · 2014-08-05FDA Approved: VALPROIC ACID — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for Valproic acid submitted by Upsher-Smith Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2014-08-04Clinical Trial Update: Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS [Phase 3]
Phase 3 long-term open-label safety extension for retigabine/ezogabine in pediatric subjects with epilepsy has been terminated; results post…
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FDA approval · 2014-08-01FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application to add Keppra XR, an extended-release formulation of levetiracetam, to the Keppra product line.
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CLINICAL_TRIALS trial_result · 2014-07-18Clinical Trial Update: Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients [Phase 3]
This update reports the completion of a Phase 3 trial evaluating eslicarbazepine acetate as add-on therapy for partial seizures in elderly p…
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FDA approval · 2014-07-03FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Dilantin (extended phenytoin sodium) by Viatris Specialty LLC. The approval concerns the extende…
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FDA approval · 2014-07-03FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2014-07-01FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for Phenytoin Infatabs (phenytoin) from Prasco Laboratories, enabling continued marketing of thi…
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CLINICAL_TRIALS trial_result · 2014-07-01Clinical Trial Update: Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures [Phase 2]
A Phase 2 trial evaluating intranasal clonazepam for adult epileptic seizures has completed, and results were posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-06-27Clinical Trial Update: Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization [Phase 4]
Phase 4 trial evaluating add-on zonisamide for adults with focal epilepsy (with or without secondary generalization); the study assessing ef…
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CLINICAL_TRIALS trial_result · 2014-06-26Clinical Trial Update: Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures [Phase 4]
Phase 4 trial comparing vagus nerve stimulation therapy to anti-epileptic drug treatment in children with refractory seizures; the study was…
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FDA label_change · 2014-06-20FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, updating regulatory information for the …
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CLINICAL_TRIALS trial_result · 2014-06-20Clinical Trial Update: A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers [Phase 1]
Phase 1 study examining diazepam administration routes (intranasal and intravenous) in healthy volunteers; completed with results posted in …
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FDA approval · 2014-06-19FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
The FDA granted a supplemental approval for Depakote Sprinkles (divalproex sodium) from AbbVie under a supplemental application.
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FDA approval · 2014-06-19FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie Inc. The approval indicates the agency has appr…
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FDA approval · 2014-06-12FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2014-06-12FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals' lamotrigine chewable dispersible as a generic lamotrigine product under an original ANDA.
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FDA approval · 2014-06-10FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
FDA supplemental approval for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC, leading to updated labeling.
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FDA approval · 2014-06-10FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC.
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FDA approval · 2014-06-10FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for LAMICTAL XR (lamotrigine) submitted by GlaxoSmithKline LLC.